The meta-analyses from 2003 and 2005 also reported on incidences of side effects (Table 1). The incidences from the 2005 meta-analysis are probably most relevant, as epidural analgesia was compared with IV PCA as opposed to a mixture of IV PCA and “as needed” (PRN) delivery. As expected, epidural and IV PCA analgesia offered different profiles of side effects with epidural analgesia associated with significantly reduced risk of nausea and sedation but significantly higher incidences of pruritus, urinary retention, and motor block. When continuous epidural analgesia was compared with epidural PCA, epidural PCA offered a reduced risk of side effects with significantly lower incidences of nausea and motor block but more frequent incidence of pruritus.
Meta-analyses confirm that epidural analgesia with continuous infusion or continuous epidural PCA delivery provides statistically superior analgesia to both mixed systemic and IV PCA delivery of opioids for at least the first three PODs for a variety of surgical procedures. Use of local anesthetics can maximize this efficacy. However, the clinical superiority of epidural analgesia (weighted mean difference in VAS approximately >20 mm) is uncertain, and may occur only with activity through the first POD. Side effect profiles differ among regimens, with IV PCA having greater risk of nausea and sedation and epidural analgesia having a higher risk of pruritus, urinary retention, and motor block. Epidural PCA has a decreased risk of motor block and nausea but increased risk of pruritus when compared with conventional continuous epidural analgesia.
Compared with continuous perineural analgesia.
Analgesia and side effects
One procedure specific meta-analysis examined continuous paravertebral blocks versus thoracic epidural analgesia with local anesthetic-containing solutions for thoracotomy (15). This meta-analysis noted similar pain scores and decreased risk of postoperative nausea and vomiting and hypotension with paravertebral blocks. Seven small RCTs have compared epidural analgesia with continuous perineural analgesia for major hip and knee surgery (16–22). Six of the RCTs used a femoral catheter and one used a psoas compartment catheter. All noted equivalent analgesia at rest and with activity with either technique. Most RCTs noted a greater risk of urinary retention (5 of 6 trials) with epidural analgesia, and a few (2 of 7) RCTs noted greater risk of nausea. Risks of sedation, pruritus, and motor block were equivalent.
Evidence from meta-analysis and small RCTs consistently indicate equivalent analgesia with epidural analgesia and continuous perineural techniques. Most RCTs noted increased risk of urinary retention with epidural analgesia.
Compared with continuous wound catheter and single shot peripheral nerve blocks.
Analgesia and side effects
One RCT has compared epidural analgesia with continuous intraarticular analgesia after anterior cruciate ligament repair (18). Analgesia at rest was equivalent except for clinically superior VAS scores at the 24 h measurement with epidural analgesia. The incidence of urinary retention was more frequent with epidural analgesia. Motor block, postoperative nausea and vomiting, sedation, and pruritus were equivalent. One RCT compared epidural analgesia with single-shot femoral and sciatic nerve blocks for total knee replacement. Analgesia and side effects were equivalent for both techniques.
There is insufficient evidence to evaluate epidural analgesia compared with either continuous wound catheters or single-shot peripheral nerve blocks.
Continuous Perineural Analgesia
Peripheral nerve blocks have become increasingly popular as a technique for acute postoperative pain management. Peripheral techniques offer potential advantages over systemic analgesic regimens in terms of better analgesia with fewer side effects than systemic opioids (23). Peripheral techniques offer more targeted sensory and motor block than central neuraxial analgesia, which typically results in minimal sympathetic block and hemodynamic disturbances (24), and may offer less risk of catastrophic complications such as spinal hematomas and abscesses.
Compared with systemic opioids.
A meta-analysis published in 2006 (19 RCTs with 603 patients) compared continuous perineural analgesia versus mixed systemic opioids (13 of 19 RCTs used IV PCA) (23). Perineural analgesia, which can be used on an ambulatory basis (25), provided statistically superior analgesia at rest and with activity for 48–72 h with a reduction in risk of nausea, sedation, pruritus but increased risk of motor block (Table 2). Clinically superior analgesia was apparent at rest for the first 24 h and with activity for the first 48 h.
Meta-analysis indicates that continuous perineural analgesia provides clinically superior analgesia for up to 48 h after surgery with reduced side effects when compared with systemic opioids.
Compared with single shot peripheral nerve block.
Analgesia and side effects
Five RCTs were identified that compared continuous lumbar plexus analgesia to single shot lumbar plexus blocks in skin grafting (28), total knee replacement (27,30,33), and ambulatory anterior cruciate ligament repair (31). No consistent findings were reported. Three RCTs reported equivalent analgesia and side effects for skin grafting and total knee replacement, whereas the other two RCTs reported statistically superior efficacy with continuous analgesia for POD 1–3 or 4 in total knee replacement and anterior cruciate ligament repair. Analgesic differences were likely to be clinically appreciable for POD 1 and 2. No differences were noted in side effects.
There is insufficient and inconsistent evidence from RCTs to confirm superior analgesic efficacy of continuous versus single shot peripheral nerve blocks.
Compared with wound catheters.
Analgesia and side effects:
One RCT was identified that compared continuous interscalene analgesia with continuous subacromial infusion after arthroscopic rotator cuff repair with interscalene block (32). Pain scores at rest and motion were statistically superior to rest and activity until POD 2. Differences were probably clinically appreciable only with activity on POD 1. Opioid-related side effects were not commented upon.
There is insufficient evidence to confirm superior analgesic efficacy of continuous peripheral nerve blocks compared with continuous wound catheters.
Continuous Wound Catheters
A promising modality that may be helpful for improving postoperative analgesia is the relatively simple technique of infusing local anesthetics directly into wounds. This technique can be widely and simply used, is technically efficient, offers the potential to provide either complete analgesia or significantly reduce need for opioids and their related side effects, may be used for several days, and may now be used on an ambulatory basis with the introduction of new portable pumps.
Compared with systemic opioids.
A meta-analysis published in 2006 compared continuous wound catheter analgesia versus placebo solution or no catheter and systemic opioids in a variety of surgical procedures (26). Wound catheter analgesia provided statistically superior analgesia with rest and activity for an average duration of 2 days with a reduction in risk of nausea (Table 3). Decreased pain scores were clinically appreciable only with activity in the orthopedic surgery subgroup.
Meta-analysis indicates that continuous wound catheter analgesia provides statistically superior analgesia with reduced side effects when compared with systemic opioids. However, clinically appreciable improvement in analgesia may only occur with activity after orthopedic surgery.
IV PCA opioid delivery.
IV PCA is routinely used for postoperative analgesia in most of the developed world. Individual variance in systemic opioid pharmacokinetics and pharmacodynamics may vary up to 10-fold, and theoretically, self-titration of opioid would provide superior efficacy and safety when compared with PRN or on-demand administration.
Analgesia and side effects
One meta-analysis compared IV PCA with PRN delivery of systemic opioid (36). IV PCA resulted in statistically significant reduction in VAS pain scores (unspecified rest or activity) for 72 h after surgery, but none of the differences were clinically significant (Table 3). IV PCA resulted in greater use of opioid in the first 24 h followed by equivalence for the next 48 h. This is the likely cause for the greater risk of pruritus with IV PCA. Other side effects were equivalent (Table 3).
Meta-analysis indicates that IV PCA delivery of opioid offers little clinical advantages over PRN delivery, although use of IV PCA may provide a statistical decrease in VAS pain scores.
Non-Opioid systemic analgesics.
Non-opioid systemic analgesics are frequently combined with opioids to improve efficacy and reduce side effects. They may act centrally or peripherally and all have a predominant mechanism of analgesia separate from opioid receptors. Non-opioid analgesics included in this review are NSAIDs, selective cyclooxygenase-2 inhibitors [COX2I], acetaminophen, ketamine, and gabapentin compared with placebo in postoperative patients receiving IV PCA opioid.
NSAIDs, Selective COX2 Inhibitors, and Acetaminophen
One meta-analysis separately evaluated all three drugs (29). Only NSAIDs resulted in a statistically significant, but probably not clinically appreciable, reduction in unspecified pain scores (Table 3). Pain scores for selective COX2 inhibitors could not be analyzed because of incompatible study methodologies. A previous systematic review noted a predominance of statistically significant reductions in pain scores with preoperative administration of selective COX2 inhibitors, but did not comment on magnitude of reduction (37). All regimens decreased morphine consumption, but only NSAIDs reduced the side effects of nausea, vomiting, and sedation. However, two recent RCTs suggest that the perioperative use of NSAIDs and acetaminophen as part of a perioperative multimodal analgesic technique may result in a reduction in pain, side effects, and long-term complications (38,39).
Perioperative Infusions of Ketamine
A meta-analysis from 2006 was identified in the Cochrane library that included 37 RCTs with 2240 patients and included in-house data from the manufacturer of ketamine (34) (Table 3). A meta-analysis of VAS scores was not performed because of differing methodologies in the included studies. However, qualitative review noted statistically significant reduction in pain scores at rest in only 54% of the treatment arms. No comments were made on the magnitude of reduction. Although morphine consumption was decreased, there were no significant differences in postoperative nausea and vomiting with ketamine (18%) versus placebo (22%) combined with IV PCA opioid for postoperative analgesia.
Perioperative Administration of Gabapentin
A meta-analysis published in 2006 (Table 3) (35) showed that unspecified pain scores were statistically decreased at 24 h, but the reduction was unlikely to have been clinically appreciable. Morphine use was reduced with gabapentin, but incidences of postoperative nausea and vomiting were not different for gabapentin (20%) versus placebo (17%). Gabapentin did increase risk of sedation.
Meta-analyses do not demonstrate clinically appreciable analgesic improvements with non-opioid analgesics, and only NSAIDs and ketamine demonstrated statistically significant reductions in pain scores. Although all non-opioid analgesics reduced opioid use, only NSAIDs reduced the risk of opioid-related side effects (nausea, vomiting, and sedation).
Methods for Systematic Review of Health-Related Quality of Life, Postoperative Quality of Recovery, and Patient Satisfaction
The National Library of Medicine's Medline and the Cochrane Library databases were searched for the past decade (Jan, 1996 to August 9, 2006). A search using the textwords “satisfaction,” “quality of life,” and “quality of recovery” (156,741 articles) were combined with a second search using the textwords “postoperative” and “analgesia” (10,729 articles), which was subsequently limited to the English language, RCTs, meta-analyses, and reviews (560 articles). Each of the 560 abstracts was reviewed for possible inclusion for this review. Inclusion criteria consisted of any systematic review or meta-analysis examining the effect of postoperative analgesia on satisfaction, health-related quality of life, or quality of recovery as a primary assessment of the review, or any RCT with satisfaction, health-related quality of life, or quality of recovery as a primary or secondary end-point. From this review, we obtained 5 RCTs assessing quality of life, 4 RCTs assessing quality of recovery, 95 RCTs assessing satisfaction.
The presence or absence of side effects and the efficacy of postoperative analgesia are potentially important components of the patient-reported outcomes of health-related quality of life, postoperative quality of recovery, and patient satisfaction. Health-related quality of life, quality of recovery, and patient satisfaction are distinct, but they may be conceptually related entities. The commonality among these patient-reported outcomes is their multidimensional character that reflects the many factors that contribute to the self-assessment of one's overall health experience (40). Most available trials (particularly in the assessment of satisfaction) have assessed these patient-reported outcomes only as a secondary end-point and may not have used validated instruments in their assessment.
Different analgesic drugs and techniques are expected to provide different levels of analgesia and incidences of side effects. For instance, when peripheral and epidural regional analgesic techniques are functioning properly (41), they would be expected to provide analgesia superior to systemic opioids (9,10,23). The different levels of postoperative pain between techniques may theoretically affect patient-reported outcomes, as higher levels of postoperative pain may be associated with an overall decrease in mental and psychological function (42,43), higher incidence of cognitive dysfunction including postoperative delirium (44), higher levels of postoperative fatigue (45,46), disturbances in sleep (47), and delayed convalescence, all of which would be expected to negatively affect patient-oriented assessments. Thus, different analgesics or techniques may affect health-related quality of life, quality of recovery, or patient satisfaction in the immediate postoperative period.
Health-Related Quality of Life
Health-related quality of life is a widely accepted end-point for clinical trials and clinical care. Health-related quality of life is the comprehensive assessment of the medical care received by a patient, with assessment conceptually incorporating physical functioning, mental health, cognitive functioning, symptoms (e.g., pain), role and social functioning, general health perceptions, sleep, and energy. Typically, it is assessed using validated instruments (either generic or specific) over a time frame of weeks to months. There are many validated health-related quality of life instruments, SF-36 being one of the most commonly used instruments. At this time, there is no validated tool to specifically assess postoperative health-related quality of life on a daily basis in the immediate postoperative period (i.e., within 1–2 wk of surgery). A comprehensive treatment of health-related quality of life is beyond the scope of this manuscript but has been recently discussed elsewhere (48).
Of the five RCTs examining postoperative health-related quality of life using instruments validated in areas outside of the postoperative period (Table 4), only one of five demonstrated any difference in health-related quality of life between analgesic techniques. In this study, patients undergoing elective colon surgery who were randomized to receive perioperative epidural analgesia (versus IV PCA) had significantly preserved quality-of-life (SF-36) for both physical and mental health at 3 and 6 wk after surgery (49). These patients also had lower postoperative pain scores, lower levels of fatigue, and earlier physical functioning at 3 wk after surgery (49). However, four other RCTs did not show any difference in health-related quality of life using different analgesic techniques. The use of preemptive epidural analgesia (before versus after incision) does not appear to have a beneficial effect on health-related quality of life at 6–12 mo after surgery (50).
Summary statement for health-related quality of life
There are insufficient data to determine if analgesic technique, degree of analgesia, and presence of side effects influences health-related quality of life. No study assessed health-related quality of life as the primary end-point (i.e., was powered to assess clinically significant differences in health-related quality of life).
Postoperative Quality of Recovery
Although health-related quality of life and postoperative quality of recovery [which was designed specifically to assess postoperative recovery on a daily basis (51)] may seem interchangeable, the two are technically distinct. Pain is assessed for both health-related quality of life and postoperative quality of recovery, as is physical condition and psychosocial functioning. As a result, changes in postoperative quality of recovery, which although technically not a quality if life instrument, may correlate with long-term changes in health-related quality of life (52).
There are at least two psychometrically developed instruments that may be used to assess postoperative quality of recovery. Probably the best instrument that has been developed is the QoR-40 (53), which is based on several dimensions of recovery, including emotional state, physical comfort, psychological support, physical independence, and pain (53). A shorter 9-item version of the QoR-40 is also available and valid in assessing postoperative quality of recovery (51). The other instrument for assessing quality of recovery is the 24-Hour Functional Ability Questionnaire, a 21-item instrument psychometrically developed to assess final recovery and satisfaction 24 h after outpatient surgery (54).
Of the four RCTs obtained from the literature search, none showed any difference in postoperative quality of recovery among differing analgesic regimens (Table 5). However, no study assessed postoperative quality of recovery as a primary end-point. As a result, the studies may have been under-powered to assess clinically significant differences in postoperative quality of recovery. Other nonrandomized data suggest that higher levels of postoperative pain correlate with a decrease in postoperative quality of recovery (56). Even though it might be expected that analgesic techniques interfering with pain conduction (e.g., epidural or continuous nerve catheters) might provide superior analgesia and thus improve postoperative quality of recovery, this may not be the case if there is no difference in pain scores between techniques (55). In addition, improved analgesia may result in increased side effects, which, in turn, may decrease postoperative quality of recovery and other patient-reported outcomes.
Summary statement for postoperative quality of recovery
There are insufficient data to determine if the type of analgesic technique, degree of analgesia, and presence of side effects influence postoperative quality of recovery. No study has assessed quality of recovery as the primary end-point (i.e., was powered to assess clinically significant differences in quality of recovery). Postoperative quality of recovery is an under-studied measurement of health-related quality of life in the immediate postoperative period.
Although assessing patient satisfaction with postoperative analgesia may seem intuitively simple, the measurement of patient satisfaction per se is complex. There may not be a direct correlation between levels of postoperative pain and patient satisfaction, since pain is only one of many components of patient satisfaction. Other important components include presence of side effects, interaction with staff, patient environment, and financial considerations (57). Nevertheless, the level of pain is one of the more important components of patient satisfaction with postoperative. 0 analgesia (58) and poor control of postoperative pain generally correlates with decreased patient satisfaction (59,60). The presence (or absence) of analgesic-related side effects may also influence patient satisfaction. A RCT comparing epidural versus spinal anesthesia for elective cesarean delivery assessing maternal satisfaction as the primary end-point and using a validated instrument for assessing satisfaction (61) noted that, although there was no difference in global satisfaction as assessed by VAS, patients who were randomized to receive spinal anesthesia had less satisfaction as a result of the presence of minor side effects, including opioid-induced pruritus. This study highlights the importance of using a psychometrically validated instrument (as opposed to a one-dimensional VAS score) to assess a complex concept such as satisfaction.
Of the 95 RCTs assessing satisfaction with different analgesic techniques, only 2 RCTs used a validated instrument to assess patient satisfaction, and only 2 assessed satisfaction as a primary end-point. The vast majority of studies used a nonvalidated one-dimensional instrument (e.g., VAS) to assess satisfaction, which is typically designated a secondary or tertiary end-point (Table 6). Approximately half of the RCTs (47 of 95) noted an improvement in satisfaction with one analgesic technique or regimen over another. When using the same technique but examining different dosages or drug classes (e.g., comparison of intraarticular bupivacaine versus ropivacaine versus morphine), only 13 of 35 RCTs noted any difference in satisfaction. When comparing different techniques or comparing with placebo/no intervention, 34 of 55 studies noted some difference in satisfaction levels. Finally, when comparing different techniques of administration of the same drug (e.g., different lockout intervals for the same epidural analgesic regimen), none of the five RCTs demonstrated any difference.
Summary statement for patient satisfaction
There are significant methodological issues, particularly the lack of use of validated instruments to assess patient satisfaction with different analgesic regimens, which preclude any definitive conclusion regarding the influence of the type of analgesic technique, degree of analgesia, and presence of side effects on patient satisfaction in the immediate postoperative period (within 2 wk of surgery). Additional large scale RCTs using validated instruments for assessing patient satisfaction as a primary endpoint are needed.
The increasing importance of patient-reported outcomes reflects, in part, societal trends in health care consumerism. In examining the effect of postoperative analgesia on postoperative patient-reported outcomes, we have examined several factors, including degree of analgesia, presence of side effects, health-related quality of life, quality of recovery, and patient satisfaction, which may influence a patient's subjective assessment of their postoperative recovery. Although regional analgesic techniques are generally associated with statistically lower VAS pain scores when compared with systemic opioids, the clinical significance of lowered VAS scores is not consistently apparent. Differences in incidences of analgesic-related side effects also influence a patient's overall assessment. As a result, a decrease in pain scores accompanied by an increase in side effects may not be perceived as an improved outcome by patients.
Despite the theoretical benefits of superior analgesia, there is a lack of high-quality data on the effect of different analgesic techniques and regimens on patient-reported outcomes such as health-related quality of life, quality of recovery, and patient satisfaction. The effect of analgesic techniques on patient-reported outcomes, particularly postoperative quality of recovery, is under-studied. Although the paucity of data on the effects of analgesic techniques on patient-reported outcomes precludes any definitive recommendations for clinical practice, future studies should be directed not only at developing validated instruments to assess these various patient-reported end-points but also at examining these outcomes as the primary end-point in RCTs. Further development of instruments assessing patient-reported outcomes in the postoperative period is needed (62).
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