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Original Article

Impact of the Fascia Iliaca Block on Pain, Opioid Consumption, and Ambulation for Patients With Hip Fractures: A Prospective, Randomized Study

Schulte, Spencer S. MDa,b; Fernandez, Isaac MDa,b; Van Tienderen, Richard MDa,b; Reich, Michael S. MDa,c; Adler, Adam MDa; Nguyen, Mai P. MDa,c,d

Author Information
doi: 10.1097/BOT.0000000000001795
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Abstract

INTRODUCTION

There are approximately 350,000 hip fractures annually.1 With an aging population, the incidence of hip fractures will continue to rise. Hip fractures and the surgical management thereof carries inherent risk for complications. Due to the morbidity and mortality related to opioid use, the US government has declared the opioid crisis a public health emergency.2 The American Academy of Orthopaedic Surgeons in partnership with the Orthopaedic Trauma Association has started a campaign to promote safe prescription and use of opioids.3

Analgesia in patients undergoing surgical fixation of hip fractures has traditionally been dependent on the use of opioid drugs, despite their many adverse effects.4,5 Opioids can oversedate patients, reducing their ability to promptly ambulate with physical therapy.6 In comparison with standard multimodal analgesia management, peripheral nerve blockade has been shown to be beneficial for opioid use, visual analog scale (VAS) score, length of stay, and postoperative ambulation.1,7–17

The fascia iliaca block (FIB) is an attractive local anesthetic option because it is fast and requires minimal training.18 The FIB has been shown to improve patients' VAS score, diminish opioid requirements and their associated side effects, and minimize discomfort associated with positioning for epidural anesthesia with minimal complications.18–27 The FIB may also decrease the postoperative length of stay for patients with operatively treated hip fractures.1,24

To the best of our knowledge, there are 4 randomized controlled trials (RCTs), evaluating the efficacy of the FIB in patients with hip fracture.22,25–27 Of these studies, 2 considered postoperative morphine consumption, 1 evaluated postoperative ambulation, and none evaluated discharge disposition. The purpose of this study is to evaluate the effect of the FIB on pain, opioid requirements, postoperative mobilization, and discharge disposition in the setting of surgically treated hip fractures.

MATERIALS AND METHODS

The RCT protocol was approved by the institutional review board, and all patients provided informed consent. The study was registered in the ClinicalTrials.gov Protocol Registration System (NCT03525977). Patients eligible for participation were identified in the emergency department from February 2018 to April 2019. Inclusion criteria included skeletally mature patients who had a low-energy, ground level fall and an isolated hip fracture (femoral neck, intertrochanteric, or subtrochanteric femur fractures) that was indicated for surgical management at a Level 1 trauma center. Exclusion criteria included patients with pathologic fractures, patients with polytrauma, nonambulatory patients, and individuals who were not able to provide consent for the study. Eligible patients were approached by a study investigator. During the consent process, all patients were informed of the risks and benefits of participation and were informed of the opportunity to exit the study at any point. Patients were further excluded if they received another regional anesthesia block besides the FIB or had their FIB performed by someone other than an anesthesia provider.

One hundred thirty patients (age range: 47–96 years) with low-energy hip fractures were eligible to participate in the study. Thirteen patients were deemed unable to provide consent, and 7 patients declined participation. An additional 4 patients were nonambulatory, 7 patients had other regional anesthesia in addition to the FIB, 1 patient received an FIB by an emergency department provider, and 1 patient had a pathologic fracture. Patients were randomly assigned to the control group or the FIB group based on the medical record number, with even numbers to receive the FIB. A total of 97 patients were included, with 57 patients randomized to the FIB group and 40 to the no-block, control group.

All FIBs were performed with ultrasound guidance by anesthesia providers preoperatively or immediately postoperatively in the postanesthesia care unit (PACU). The block used 45–60 mL 0.375% ropivacaine. All patients had a general anesthetic. Intraoperative periarticular blocks or local anesthetic agents were not used. Patients were weaned from intravenous to oral pain medications as tolerated, using opiate and nonopiate medications, for both groups.

Primary outcomes were the VAS scores, morphine milligram equivalents (MMEs), effects of opiate consumption, postoperative 72-hour ambulatory distance, and block-associated complications. Opioid consumption was recorded from each patient's chart and converted to an MME. Patients were instructed to use a 10-point VAS to describe their level of pain and was recorded preoperatively, in the PACU, and every 4 hours until discharge by the nursing staff. The VAS score was recorded as a daily average, whereas MME and ambulatory distances were reported as daily totals and the sum total from surgery to postoperative day (POD) 3. The operative team was not involved in recording any outcome measure. All patients were made weight bearing as tolerated, and physical therapists mobilized patients postoperatively, starting on POD 0 or POD 1 depending on the time of the day of surgery, recording the daily walking distance.

Secondary outcomes were postoperative complications, opioid-related complications, length of stay, and discharge disposition. Complications included cerebrovascular incidents, myocardial infarction, dysrhythmias, chronic medical condition exacerbation, pneumonia, deep vein thrombosis, pulmonary embolus, blood transfusion, acute kidney injury, electrolyte abnormalities, and urinary tract infection. Opioid-related complications included constipation, hypoxia, urinary retention, and altered mental status. Discharge disposition was categorized into skilled nursing facility and in-patient rehabilitation, long-term acute care and hospice, and out-patient rehabilitation and home health.

Statistical Analysis

An a priori power analysis was performed to detect a clinically significant difference in the VAS score of 1.3 points (power = 80%, P = 0.05).28 This determined that a minimum of 47 patients per group was required. Statistical analyses were completed using R 3.4.3 (R Foundation for Statistical Computing, Vienna, Austria). Continuous variables were analyzed for normality using Shapiro–Wilks and Anderson–Sterling tests. Normally distributed data were reported as mean and SD, and compared using the Student t test or Welch t test. Nonparametric data were reported using the median and interquartile range (IQR) and compared using Mann–Whitney U tests. Categorical variables were analyzed using the Fisher exact test or Pearson χ2 test. Statistical significance was defined as α < 0.05.

RESULTS

Ninety-seven patients were included in the final analysis. Fifty-seven patients were randomized to the FIB group and 40 patients to the control group. Based on the original randomization, there were no differences between the groups in any demographic characteristics including age, sex, American Society of Anesthesiologists classification, smoking status, pre-existing chronic pain, preinjury functional status, fracture type, and type of surgery (Table 1). The FIB was administered preoperatively for 45 patients (88%) and immediately postoperatively in the PACU for 6 patients (12%).

TABLE 1. - Demographic Data (Intent-to-Treat Analysis)
Block (n = 57) Control (n = 40) P
Age, y* 77 (9) 74 (11) 0.15
Female 37 (64.9) 31 (77.5) 0.27
Smokers 18 (31.6) 8 (20.0) 0.30
Chronic pain 4 (7.0) 7 (17.5) 0.19
ASA classification
 2 17 (29.8) 13 (32.5) 0.42
 3 36 (63.2) 21 (52.5)
 4 4 (7.0) 6 (15.0)
Fracture type
 Femoral neck 19 (33.3) 18 (45.0) 0.48
 Intertrochanteric 35 (61.4) 20 (50.0)
 Subtrochanteric 3 (5.3) 2 (5.0)
Type of surgery
 Screw fixation 2 (3.5) 2 (5.0) 0.85
 Cephalomedullary nail 37 (64.9) 23 (57.5)
 Arthroplasty 18 (31.6) 15 (37.5)
OTA/AO classification, n
 31A1 12 12 0.06
 31A2 16 7
 31A3 6 1
 31B1 7 11
 31B2 11 6
 31B3 1 2
 32A3 4 0
 32C1 0 1
*Mean (SD).
n (%).
ASA, American Society of Anesthesiologists.

Twelve patients received the FIB who were randomized to not receive the block, and 18 patients who were randomized to receive the FIB crossed over to the control group (Table 2). Patients did not provide explanations for crossing-over. Compared with patients who crossed from the FIB group to the control group, patients who crossed from the control group to the FIB group had a higher VAS score on POD 1 (2 vs. 0, P = 0.047) and trended toward being younger (72 vs. 78 years, P = 0.09), having a higher VAS score on POD 2 (6 vs. 3, P = 0.06), and consuming more MMEs on POD 3 (11 vs. 5, P = 0.06) and cumulatively (40 vs. 20, P = 0.10). Although not statistically significant, the group that crossed over to the FIB group rated their pain as being greater than the group that crossed over to the control group at all time points, consumed a cumulatively greater number of MMEs, and consumed a greater number of MMEs at all time points.

TABLE 2. - Cross-over Characteristics and Outcomes
Cross-over to the Block (n = 12) Cross-over to the Control (n = 18) P
Age, y* 72 (11) 78 (8) 0.09
Female 9 (75.0) 12 (66.7) 0.70
Smokers 3 (25.0) 7 (38.9) 0.69
Chronic pain 2 (16.7) 0 (0) 0.15
VAS
 PACU 0 (0–2) 0 (0–0) 0.42
 POD 1 2 (0–6) 0(0–0) 0.05§
 POD 2 6 (4–8) 3 (0–5) 0.06
 POD 3 3 (0–6) 1 (0–4) 0.56
MME
 Pre-op 17 (14–25) 14 (8–18) 0.13
 POD 0 4 (0–11) 0 (0–5) 0.21
 POD 1 10 (5–21) 8 (1–15) 0.32
 POD 2 14 (4–18) 5 (0–17) 0.31
 POD 3 11 (7–20) 5 (0–9) 0.06
 Total 40 (23–68) 20 (9–43) 0.10
Cumulative ambulation, feet
 Total 50 (29–104) 32 (3–160) 0.63
*Mean (SD).
n (%).
Median (IQR).
§Statistically significant.

Intent-to-Treat Analysis

There was no difference in the rate of opioid-related, block-related, or medical complications between groups (Table 3). There was a statistically significant difference in preoperative MMEs (13 for the FIB vs. 17 for the control group, P < 0.05). On POD 2, the FIB group's VAS score trended toward being lower than that of the control group (0 vs. 2, P = 0.06) and demonstrated increased ambulation (25′ vs. 2′, P = 0.09). FIB group patients were more likely to be discharged home, as opposed to requiring a higher level of care upon discharge (51% discharged home vs. 32.5%, P = 0.054).

TABLE 3. - Outcomes
Intent-to-Treat As-Treated Per-Protocol
Block (n = 57) Control (n = 40) P Block (n = 51) Control (n = 46) P Block (n = 39) Control (n = 28) P
Complications*
 Opioid-related 11 (19.3) 8 (20.0) 1 9 (17.6) 10 (21.7) 0.84 8 (20.5) 7 (25.0) 0.89
 Block-related 0 (0) 0 (0) 1 0 0 1 0 0 1
 Medical 25 (43.9) 22 (55.0) 0.38 24 (47.1) 23 (50.0) 0.84 18 (46.2) 16 (57.1) 0.52
VAS
 PACU 0 (0–0) 0 (0–0) 0.19 0 (0–0) 0 (0–0) 0.67 0 (0–0) 0 (0–0) 0.31
 POD 1 5 (2–7) 4 (0–6) 0.12 5 (2–7) 4 (0–6) 0.53 5 (1–6) 4 (2–7) 0.60
 POD 2 0 (0–3) 2 (0–6) 0.06 0 (0–5) 0 (0–4) 0.73 0 (0–4) 1 (0–6) 0.35
 POD 3 3 (0–5) 3 (0–6) 0.89 3 (0–5) 2 (0–4) 0.49 3 (0–5) 3 (0–6) 0.79
MME
 Pre-op 13 (5–18) 17 (7–27) 0.04 13 (5–19) 15 (7–20) 0.46 11 (5–18) 15 (6–29) 0.13
 POD 0 0 (0–5) 1 (0–8) 0.32 2 (0–6) 0 (0–7) 0.66 0 (0–5) 1 (0–8) 0.75
 POD 1 8 (3–15) 11 (5–18) 0.26 10 (5–15) 10 (1–18) 0.97 8 (3–15) 11 (5–18) 0.51
 POD 2 8 (3–15) 10 (5–16) 0.29 9 (5–16) 8 (1–15) 0.64 8 (5–15) 10 (5–15) 0.63
 POD 3 5 (0–13) 10 (0–15) 0.44 9 (5–15) 5 (0–15) 0.25 8 (3–15) 6 (0–15) 0.81
 Total 23 (15–43) 32 (13–55) 0.28 28 (19–49) 24 (13–50) 0.40 28 (19–43) 32 (15–46) 0.80
Ambulation, feet
 POD 1 12 (4–36) 9 (2–29) 0.81 12 (4–36) 9 (2–29) 0.42 12 (4–31) 10 (4–29) 0.74
 POD 2 25 (2–56) 2 (0–27) 0.09 25 (1–49) 10 (0–30) 0.18 30 (3–60) 10 (0–26) 0.09
 POD 3 30 (3–100) 18 (0–50) 0.27 30 (10–70) 10 (0–70) 0.15 30 (10–100) 12 (0–50) 0.12
 Total 85 (10–210) 43 (20–138) 0.47 85 (23–174) 33 (9–173) 0.13 85 (18–220) 33 (18–170) 0.21
Length of stay, d 5 (4–6) 6 (4–7) 0.74 5 (4–6) 5 (4–7) 0.31 5 (4–6) 5 (4–6) 0.83
Disposition*
 SNF/IPR 28 (49.1) 25 (62.5) 0.05 27 (52.9) 26 (56.5) 0.34 18 (46.2) 16 (57.1) 0.14
 LTAC/hospice 0 (0) 2 (5.0) 0 2 (4.3) 0 (0) 2 (7.1)
 OPR/HH 29 (50.9) 13 (32.5) 24 (47.1) 18 (39.1) 21 (53.8) 10 (35.7)
*n (%).
Median (IQR).
Statistically significant.
HH, home health; IPR, in-patient rehabilitation; LTAC, long-term acute care; OPR, out-patient rehabilitation; SNF, skilled nursing facility.

As-Treated Analysis

In the as-treated analysis, 51 patients were in the FIB group and 46 patients were in the control group. In this analysis, there were no statistically significant differences in demographics, surgery performed, outcomes measured, and discharge disposition (Table 3).

Per-Protocol Analysis

A per-protocol analysis was also performed, in which all patients who crossed over between groups were excluded. This analysis resulted in 39 FIB patients and 28 control patients. In this analysis, there were no demographic differences between groups and no statistically significant differences in outcomes between groups. The ambulatory distance of the FIB group trended toward being favored on POD 2 (30′ vs. 10′, P = 0.09).

DISCUSSION

It is recognized that early rehabilitation and minimizing opioid use in elective and orthopaedic trauma surgery plays a role in optimizing patient outcomes. This prospective, randomized controlled study demonstrated that a single perioperative FIB for patients with hip fractures may play a role in reducing pain, minimizing opioid consumption, and promoting postoperative ambulation particularly in the first 48 hours after surgery while the effects of the block are still lasting and also help patients return to their home after discharge.

Several studies have demonstrated that the FIB can decrease VAS scores and opioid medication requirements.18–26 Pain after hip fractures is associated with poor outcomes.29,30 This is the first RCT to establish a potential link between administration of the FIB, improved early pain control, and functional outcomes. We showed that improving pain control for patients with operatively treated hip fractures improves objective outcomes such as ambulatory distance and discharge disposition. Maximizing patient independence and the likelihood for patients to return home has significant implications in terms of cost-consciousness, health care system utilization, and patient satisfaction.31 In a systematic review on pain control for hip fractures, Abou-Setta et al32 were unable to recommend for or against the FIB based on 3 studies they reviewed. This study adds to the body of literature in support of the use of the fascia iliaca block for hip fractures.

Our study has notable limitations. Cross-over is a persistent challenge for prospective randomized control studies. We strived to respect patient wishes and autonomy, at the same time encouraging study participation. As a result, we did observe a 30% cross-over rate. Our analysis of the cross-over groups suggested that the group crossed over from control to block had more pain, consumed more MMEs, and wished to try other modality for pain control. In light of this limitation, we performed intention-to-treat, as-treated, and per-protocol analysis to minimize the bias introduced from crossing-over and to try to find true differences between the cohorts.

Another limitation of our study is a lack of blinding. Patients enrolled in the study were not blinded in receiving the FIB, and this could have influenced their perception of outcomes.33 Moreover, although the staff involved in recording MMEs and ambulation distance were not part of the surgical team, they were also not blinded to which cohort the patients belonged. In addition, our study excluded patients with dementia. Patients with dementia make up a significant portion of patients with fragility hip fractures (10% in the current study). Exclusion of patients with dementia increased the reliability of VAS reporting but also made our study population less representative of geriatric hip fractures.34 We also acknowledge variation in the timing of FIB administration (88% administered preoperatively and 12% postoperatively) may introduce noise when interpreting MME and VAS data.

Our study highlights the ease of FIB implementation for patients with hip fracture. There were no FIB-related complications in our study. The use of ultrasonography allows for quality control and standardization of the technique across different providers. At our institution, members of both the anesthesia team and the emergency department have begun performing the FIB. The FIB itself requires approximately 5 minutes of time, supplies for a local anesthetic injection, and point-of-care ultrasound. All of which, aside from perhaps time, are readily available in a modern emergency department.

Future directions for the study of pain management in the setting of hip fractures should have larger cohorts and include patients with dementia to detect effects of multimodal analgesia. Additional functional benefits of the FIB for pain control in hip fractures could be detected by expanding follow-up to include the postdischarge period. This would help discern whether the functional benefits we found have a lasting effect after the patient leaves the hospital. Potentially, a double-blinded RCT involving a sham block procedure would improve the study design and minimize the cross-over rate. A comparative study is needed for the different blocks (eg, FIB, femoral nerve, and surgical site) and their efficacy for specific hip fracture type (intracapsular vs. extracapsular).

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Keywords:

hip fracture; fascia iliaca block; complications; VAS; ambulation; disposition

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