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Original Article

Pain relief following breast augmentation surgery: a comparison between incisional patient-controlled regional analgesia and traditional oral analgesia

Rawal, N.*; Gupta, A.*; Helsing, M.; Grell, K.; Allvin, R.*

Author Information
European Journal of Anaesthesiology: December 2006 - Volume 23 - Issue 12 - p 1010-1017
doi: 10.1017/S0265021506000883
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Abstract

Introduction

A large proportion of patients undergoing ambulatory surgery continue to experience considerable pain at home [{L-End} 1–3]. A recent meta-analysis has shown that 45% of discharged outpatients suffer moderate to severe pain at home [{L-End} 4]. The problem of under-managed pain is greater in certain categories of patients, which includes patients undergoing breast augmentation surgery [{L-End} 3,{L-End} 5]. In many patients the commonly used analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, and weak opioids may be inadequate in providing effective pain relief at home [{L-End} 6]. The use of strong opioids is controversial. It seems to be used more frequently in USA than in most other countries where it is generally discouraged in unsupervised patients at home because of the risk of potentially life-threatening respiratory depression. A technique has been described that uses disposable elastomeric pumps and allows day-surgery patients to self-administer local anaesthetic at home via incisional, intra-articular, or perineural catheters for a variety of surgical procedures [{L-End} 7]. However, there are no studies comparing incisional PCRA with standard of care, i.e. traditional analgesic techniques.

This study was designed to compare the analgesic efficacy of incisional PCRA with standard-of-care analgesic combination of paracetamol and ibuprofen in patients undergoing breast augmentation surgery as an ambulatory procedure. A second aim was to compare the analgesic efficacy between ropivacaine 0.25% and 0.5%.

Methods

Sixty patients were consecutively enrolled in this prospective, randomized study that was approved by the Hospital Ethics Committee. All patients were scheduled for elective cosmetic breast augmentation surgery. The inclusion criteria were: ASA physical status I or II, age 18 yr or older, clear understanding of the study protocol including care of catheter and elastomeric pump system, and also possible local anaesthetic-related complications. Exclusion criteria included a history of opioid dependence, allergy to study medications, chronic analgesic treatment, hepatic or renal insufficiency, and coagulopathy.

Anaesthetic technique

All patients received oral premedication with diazepam 5 mg and paracetamol 1 g. Surgery was performed under local infiltration anaesthesia with monitored anaesthesia care (MAC). Routine monitoring included pulse-oximetry, electrocardiography and automated blood pressure measurement throughout the surgical procedure and in the post-anesthesia care unit (PACU). If necessary, patients received titrated doses of alfentanil 0.5–1.0 mg intravenous (i.v.) for analgesia and midazolam 2.5 mg i.v. for sedation. General anaesthesia was administered if these measures were inadequate. At the end of surgery, the patients were assigned randomly to two groups of 30 patients each using a computer-generated list of random numbers: patients in Group PCRA received a subcutaneously placed multiple-hole catheter through the incision along the periphery of each breast. Each catheter was attached to a bacterial filter and an elastomeric, disposable pump (I-Flow, Lake Forest, USA) filled with 100 mL of local anaesthetic. Patients in Group T (tablet) did not receive a subcutaneously placed multiple-hole catheter but were randomized to the tablet group, which has been the standard of care at our hospital for several years (see below for details). In the PACU, postoperative pain was treated by i.v. morphine 1–2 mg until pain score on a 10 cm visual analogue scale (VAS) was ≤3.

Group PCRA

The technique of PCRA has been described earlier [{L-End} 4]. Patients in this group were instructed to self-administer a 10 mL bolus of local anaesthetic when necessary for pain relief (pain score >3). In order to study the appropriate dose of ropivacaine for adequate analgesia, all patients received ropivacaine 0.25% in the left breast and ropivacaine 0.5% in the right breast. The patients were informed that the concentration of local anaesthetic in each breast would be different, however, to achieve patient blinding they were not informed about the selected concentration for each breast. To confirm that the patient understood the pump function she was asked to self-administer the first dose of local anaesthetic under nurse supervision in the PACU before discharge. The patient and her carer were then given verbal and written standard postoperative instructions, and also instructions regarding the use of the elastomeric pump, analgesic tablets, and rescue medication. Each pump had a total of 100 mL local anaesthetic. The patients were informed that they had nine doses (90 mL) of study medicine and that they should start the drug administration as soon as they experienced pain in the surgical area. Each self-administration delivered 10 mL of local anaesthetic. Specific instructions were given about symptoms and signs of local anaesthetic toxicity and wound infection. Telephone and pager numbers of the responsible physicians were given to the patients and 24-h access to the hospital emergency room was available. The patients were also instructed to remove the catheters and discard the pump when they no longer needed pain relief (usually 1–2 days). If the patients did not want to remove the catheters themselves, they had the option of going to the nearest ‘district nurse’ (available all over the country as part of the nationalized Swedish Health Care system) or the nursing staff or the surgeon involved with the surgery. Each patient received a logbook, which included separate pages for each of the possible nine home treatments. Each time the patient used the Home pump, she recorded the VAS before and 20 min after treatment in the logbook. The patient also graded her analgesia on a 5-point scale (1: no pain relief; 2: <50% pain relief; 3: 50% pain relief; 4: >50% pain relief; 5: total pain relief). This assessment was made on the day of surgery and the day after surgery, separately for the left and right breasts. Other observations included: use of rescue medication, side-effects, technical problems, and suggestions for improvement.

Group T

Patients in this group received oral analgesic medication according to the hospital routine, this included oral paracetamol 1 g four times a day and ibuprofen 500 mg three times a day. The patient logbook included separate pages for self-assessment of pain intensity at six different time intervals for left and right breast at the following times: (1) arrival at home, (2) 3 h after arrival, (3) at bedtime, (4) on waking up the day after surgery, (5) at 4.00 p.m., and (6) at bedtime the day after surgery. The patients were also asked to grade the efficacy of their analgesia on a 3-point scale (1: ‘too weak’; 2: adequate; 3: ‘too strong’). Patients in both groups were also asked to note the following for day 1 and day 2 in their logbook: (a) sleep problems on the night of surgery and night after surgery, (b) if they woke up due to pain during the two nights, (c) any adverse effects (nausea, vomiting, sedation, dizziness, breast distension), (d) satisfaction with the treatment on a 4-point scale. Global assessment of average pain in left and right breast for day 1 and day 2 after surgery was also recorded. Patients were asked if they would or would not choose the same analgesic treatment again.

For rescue analgesia at home, all patients in both groups received dextropropoxyphene 100 mg tablets; these tablets could be taken up to three times a day.

Statistical analysis

For statistical analysis, Statview 4.0 (Statsoft Inc., Tulsa, USA) was used. Group size was determined by using proportions sample size estimated to detect a 25% decrease in VAS scores and an assumed standard deviation (SD) of 25 mm. We calculated that 24 patients would be needed in each arm of the study with an α error of 0.05 and β error of 0.1, assuming a normal distribution and a two-tailed test. Analysis of variance (ANOVA) was used for comparison of group differences. A Fisher's probable least-squares difference (PLSD) test was used as the post hoc test when differences were found to be statistically significant. Patient data were analysed using the unpaired t-test while the chi-square test (with Yates continuity correction where appropriate) was used for analysis of ordinal data. In case of normal distribution, numerical variables are expressed as mean ± SD, all others as median (range). The presence of side-effects was evaluated by using Fisher exact test. Statistical significance was assumed at P < 0.05.

Results

All 60 patients initially randomized were also included in the study. Demographic data concerning the patient's age, duration of surgery, and duration of anaesthesia were similar in both groups (Table 1). One patient in each group required general anaesthesia and overnight stay. The same surgeon performed all procedures. Intraoperative local anaesthetic and midazolam requirements were similar between the groups (Table 2). Significant differences were, however, seen in the dose of alfentanil given during the operation between the groups (Group T >Group PCRA) (P < 0.05).

Table 1
Table 1:
Patient characteristics data and duration of operation and anaesthesia are presented.
Table 2
Table 2:
Doses of drugs used per- and post-operatively.

Postoperative analgesia

There was no difference between the groups regarding pain scores at discharge from the PACU. Significantly more patients in Group T required morphine in the PACU compared to Group PCRA (25 vs. 7) (P = 0.01). The mean dose of i.v. morphine in the PACU was also significantly greater in Group T compared to Group PCRA (Table 2). The need for rescue medication in the PACU was similar between the groups on day 1 and day 2 (Table 2).

Group PCRA.

Pain scores before and after treatment for the right and left breasts on the eight occasions that the patient self-administered analgesics are shown in Figures 1 and 2, respectively. There was a significant reduction in pain scores at all times in both the left and right breasts after treatment. However, no differences in pain scores were seen between the left and right breasts.

Figure 1.
Figure 1.:
VAS are shown at different time points postoperatively in Group PCRA before (black) and after (grey) self-administered boluses of ropivacaine 0.5%. R: right breast; *P < 0.05.
Figure 2.
Figure 2.:
VAS are shown at different time points postoperatively in Group PCRA before (black) and after (grey) self-administered boluses of ropivacaine 0.25%. L: left breast; *P < 0.05.

Group T.

The mean ± SD pain scores at the six specified times were as follows: on arrival at home 5.7 ± 2.4, 3 h after arrival 5.5 ± 1.9, at bedtime 5.0 ± 2.6, on waking up on day after surgery 4.7 ± 2.4, at 16:00 day after surgery 4.1 ± 1.9, at bedtime 3.9 ± 2.2.

Global pain assessment.

The 5-point global pain assessment was done separately for left and right breast because pain intensity after breast augmentation surgery may not be the same in both breasts. The number of patients who had more than 50% pain relief was significantly greater in Group PCRA compared to Group T both on day 1 and day 2 (Table 3). There was, however, no difference in pain relief between the left and right breasts (Table 3).

Table 3
Table 3:
Postoperative analgesia

Significantly more patients in Group T required rescue analgesic tablets at home on the day of surgery compared to Group PCRA (20 vs. 11) (P = 0.02). Although more patients in Group T needed rescue analgesia on the day after surgery compared to Group PCRA, this did not reach statistical significance (15 vs. 12).

Sleep disturbance.

During the first night after surgery significantly more patients in Group T had sleep disturbance and woke up due to pain (Table 4). During the second night again significantly larger number of patients woke up due to pain in the tablet group.

Table 4
Table 4:
Post-discharge assessment of patients is shown.

Other side-effects.

In the early postoperative period, nausea or vomiting requiring treatment was seen more frequently in Group T compared to Group PCRA (10 vs. 3) (P < 0.05). At home a significantly larger number of patients in tablet group had nausea both on day 1 and day 2 (Table 4). The commonest problem in both groups was backache because of the nature of surgery as well as the need to lie supine due to surgeon instructions. Three patients complained of dizziness due to tablets and one patient in PCRA group complained of leaking of fluid in the bandage.

Patient satisfaction.

All 60 patients (100%) returned their patient logbooks. None of the patients had problems with self-administering the local anaesthetic bolus when they needed pain relief or indicating their pain intensity by VAS in the logbook. None of the patients felt the need for pump after 2 days, and catheters were withdrawn on day 3. In spite of adequate analgesia four patients were dissatisfied with the PCRA technique due to unpleasant feeling of catheter removal. One patient who was dissatisfied with PCRA regretted her decision to remove her catheters on the day of surgery, she had considerable pain in spite of tablets. The majority of patients were satisfied, some commented that it was difficult to answer this question since they were undergoing surgery the first time and had nothing to compare with. The main reasons for dissatisfaction in the PCRA group were persistent numbness in the breasts (n = 4), inadequate analgesia (n = 2), and unpleasant feeling during catheter removal (n = 3). The reasons for dissatisfaction with tablets were predominantly inadequate analgesia and nausea.

Wound healing.

There was no wound infection and wound healing was good in 59 of 60 patients. One patient in the tablet group had signs of localized infection in a small area (<1 cm2) two weeks after surgery, there were no signs of infection at the 1 week control. This patient responded to antibiotic treatment.

Discussion

The results of this study provide evidence that patients receiving PCRA with ropivacaine experienced better pain relief, required less rescue analgesics, had less sleep disturbance and nausea, and woke up less often at night due to pain than their counterparts receiving analgesia with paracetamol and ibuprofen tablets. The analgesic effects of ropivacaine 0.25% were similar to those of ropivacaine 0.5%. Self-administered local anaesthetic boluses were consistently effective. All patients could use the PCRA technique without problems.

The proportion of patients undergoing ambulatory surgery on a day care basis is increasing. In the USA, it is estimated to be in the range of 60–70% of all surgical procedures. A recent meta-analysis has shown that pain at home is the most common complaint for patients undergoing ambulatory surgery, and was experienced by 45% of patients [{L-End} 4]. In a survey of 1035 patients, we have reported that about 40% of patients have pain at home and the patients most likely to have moderate to severe pain are those undergoing skeletal surgery, breast augmentation, and inguinal hernia repair [{L-End} 3]. Similar results were reported in a survey of 5703 patients in Canada where the percentage of patients with moderate to severe pain remained unchanged at about 30% in spite of implementation of a multimodal analgesia regimen, the main reason being that inpatient surgical procedures were now being done as ambulatory surgery [{L-End} 5]. The traditional method of treating postoperative pain after ambulatory surgery is by paracetamol (acetaminophen), NSAIDs, and weak opioids such as codeine and dextropropoxyphene [{L-End} 1,{L-End} 2,{L-End} 4]. However, these drugs may not be adequate for many patients [{L-End} 3,{L-End} 4]. The use of strong opioids such as oxycodone and morphine to manage postoperative pain is controversial. It seems to be relatively common in USA but is generally avoided in most other countries because of the risk of respiratory depression in the unsupervised patient at home. We have described a technique which allows the patient to self-administer local anaesthetic from an elastomeric pump through a catheter placed subcutaneously, perineurally, or intra-articularly [{L-End} 7]. In recent years, perineural and incisional catheter techniques have been used to treat moderate to severe pain at home [{L-End} 7–9].

This study has confirmed the feasibility of the technique for breast surgery, the pump system worked well without technical problems and the patients were able to remove the catheter at home although medical facilities were available if deemed necessary. However patient satisfaction with PCRA was not as high as in our previous studies [{L-End} 7,{L-End} 10]. Four patients (13.4%) were dissatisfied with PCRA, inadequate pain relief was the reason in only one patient but all four patients were dissatisfied due to the unpleasant ‘queasy’ feeling at the time of removal of subcutaneous catheters. Additionally, four other patients used an extra dose of local anaesthetic to avoid the unpleasant feeling of catheter removal. All patients were aware that they could go to the nearest district or surgical nurse for catheter removal but they chose not to.

Patient satisfaction is influenced by many factors; in this study the satisfaction scores were similar in both groups. However, the reasons for dissatisfaction were quite different. The main reasons for dissatisfaction in the tablet group were inadequate analgesia, nausea, and sleep problems while in the PCRA group it was the unpleasant feeling at the time of self-removal of catheter and feeling of numbness in the breasts. Since higher concentration of ropivacaine did not give better analgesia, recommending lower concentration of ropivacaine, and removal of catheter by a nurse may improve satisfaction with PCRA technique.

This study confirmed results from several studies that traditional analgesic medication may not be effective for postoperative pain relief in a considerable number of ambulatory surgery patients [{L-End} 1–5]. The problem is particularly marked in patients undergoing orthopaedic surgical procedures, inguinal hernia, and breast augmentation surgery. In spite of oral paracetamol, ibuprofen, and rescue dextropropoxyphene 30–40% patients were dissatisfied with pain relief [{L-End} 3,{L-End} 5]. In the tablet group, 57% patients had sleep disturbance, 77% woke up due to pain, and 47% had nausea, which was significantly higher than those receiving PCRA. These problems were somewhat reduced the day after surgery but sleep disturbances and nausea were still significantly greater. Only 50% of patients expressed the desire to have tablets again, a majority would prefer the combination of paracetamol, ibuprofen, and dextropropoxyphene. Although analgesia with PCRA was significantly better than that with tablets, 33% patients still required some rescue medication on the day of surgery and 40% the day after. The very low incidence of nausea and better sleep pattern were a major advantage with the PCRA technique. This study shows that patients undergoing ambulatory surgery should also get antiemetic tablets or prescription in addition to the regular (over-the-counter) analgesics because not only is the risk of inadequate analgesia with mono-therapy relatively high [{L-End} 1,{L-End} 2], but also many patients have post-discharge nausea and vomiting for 1–2 days. Better sleep pattern with PCRA was most likely due to better analgesia and reduced incidence of nausea.

The inadequacy of paracetamol, NSAIDs, and weak opioids has led to the use of strong opioids such as oxycodone with or without paracetamol (acetaminophen) for very painful ambulatory surgical procedures [{L-End} 11–13]. A controlled release formulation of oxycodone (OxyContin) has been used to provide sustained pain relief and better compliance [{L-End} 11]. However, the use of strong opioids to treat acute pain in unsupervised patients is controversial. All strong opioids are associated with the well-known side-effects such as nausea, vomiting, dizziness, somnolence, constipation, and the rare but dangerous risk of respiratory depression. Oxycodone has also been associated with many of these opioid side-effects [{L-End} 12–14]. Furthermore, the onset of analgesia with controlled-release oxycodone takes about 1 h [{L-End} 15]. There is also the risk of abuse of the drug by patients due to the potential to produce physical dependence [{L-End} 16,{L-End} 17]. These problems are significantly reduced or eliminated by the use of local anaesthetic-based analgesic techniques.

A limitation of this study is that a placebo group was not included. Although our patients were unaware of the drugs and dosages, clear differences in the treatment modalities may have biased patients. However, the aim of the study was to evaluate the feasibility and effectiveness of PCRA compared to standard of care treatment. Furthermore, several studies have shown that incisional catheter techniques using local anaesthetics provide superior analgesia when compared with saline placebo [{L-End} 10,{L-End} 18–20]. A confounder was that pain intensity was not scored at the same time in the two groups because of the nature of the study, i.e. comparison of oral analgesics given at fixed time intervals in keeping with general recommendations vs. self-administered local anaesthetics on demand, and hence a considerable variation in PCRA use. Another confounder was the use of larger dose of alfentanil during surgery in the tablet group, the reason for this is unclear but it could have influenced subsequent data. Finally, sub-group analysis of data such as comparison of analgesic efficacy of 0.25% vs. 0.5% ropivacaine in the left and right breasts may not provide adequate power to detect differences between groups. Thus, more studies are needed in the literature to confirm or refute our findings.

In conclusion, this randomized-controlled trial has shown that in patients undergoing ambulatory breast augmentation surgery, self-administration of incisional local anaesthetic by PCRA provides superior pain relief compared to that provided by a combination of oral paracetamol and ibuprofen. Patients receiving PCRA with ropivacaine also had less nausea and less sleep disturbance at night. Ropivacaine 0.25% 10 mL boluses by incisional PCRA were as effective as ropivacaine 0.5% 10 mL boluses.

Acknowledgements

The authors wish to thank Nycomed, Sweden for the PCRA pumps and Marianne Welamsson for secretarial assistance.

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Keywords:

PAIN ACUTE AND POSTOPERATIVE; SURGERY, AMBULATORY; SURGERY, PLASTIC; ANAESTHETICS LOCAL, ropivacaine

© 2006 European Society of Anaesthesiology