Orthopedics

Feature Article 

Efficacy of Adductor Canal Block With Liposomal Bupivacaine: A Randomized Prospective Clinical Trial

Morteza Meftah, MD; Suhas Boenerjous-Abel, MD; Vinay H. Siddappa, MD; Ira H. Kirschenbaum, MD

Abstract

This study compared the postoperative analgesic efficacy of liposomal bupivacaine as a single-administration adductor canal block (ACB) vs periarticular injection (PAI) for pain control after total knee arthroplasty (TKA). From May 2016 to June 2017, a total of 70 unilateral TKA patients were randomized into 2 groups: PAI (extended-release bupivacaine 266 mg [20-mL vial] with 20 mL of 0.5% bupivacaine hydrochloride and normal saline to a total volume of 120 mL) and ACB (subsartorial saphenous nerve using extended-release bupivacaine 266 mg [20-mL vial]). All patents underwent spinal anesthesia with comprehensive preemptive and postoperative multi-modal pain protocol. All opioids administered were converted to morphine equivalents. Pain was recorded at 4 to 12 hours on the day of surgery, and on postoperative days 1, 2, and 3. Patients and investigators other than the surgeon and anesthesiologist were blinded to the study. The difference in pain scores between the PAI and ACB groups was not statistically significant during the first 12 hours (day 0) after surgery or on postoperative day 1 (5.31 vs 4.26, P=.091). However, on postoperative day 3, the mean pain score increased in the ACB group and decreased in the PAI group (4.8 vs 1.83, P=.037). There was no statistically significant difference between the 2 groups regarding the accumulative daily converted morphine equivalent consumption or total consumption. Although the PAI group demonstrated longer lasting pain relief than the ACB group for the duration of the study, other outcomes were similar between the 2 groups. [Orthopedics. 2020; 43(1):e47–e53.]

Abstract

This study compared the postoperative analgesic efficacy of liposomal bupivacaine as a single-administration adductor canal block (ACB) vs periarticular injection (PAI) for pain control after total knee arthroplasty (TKA). From May 2016 to June 2017, a total of 70 unilateral TKA patients were randomized into 2 groups: PAI (extended-release bupivacaine 266 mg [20-mL vial] with 20 mL of 0.5% bupivacaine hydrochloride and normal saline to a total volume of 120 mL) and ACB (subsartorial saphenous nerve using extended-release bupivacaine 266 mg [20-mL vial]). All patents underwent spinal anesthesia with comprehensive preemptive and postoperative multi-modal pain protocol. All opioids administered were converted to morphine equivalents. Pain was recorded at 4 to 12 hours on the day of surgery, and on postoperative days 1, 2, and 3. Patients and investigators other than the surgeon and anesthesiologist were blinded to the study. The difference in pain scores between the PAI and ACB groups was not statistically significant during the first 12 hours (day 0) after surgery or on postoperative day 1 (5.31 vs 4.26, P=.091). However, on postoperative day 3, the mean pain score increased in the ACB group and decreased in the PAI group (4.8 vs 1.83, P=.037). There was no statistically significant difference between the 2 groups regarding the accumulative daily converted morphine equivalent consumption or total consumption. Although the PAI group demonstrated longer lasting pain relief than the ACB group for the duration of the study, other outcomes were similar between the 2 groups. [Orthopedics. 2020; 43(1):e47–e53.]

Adequate pain management after total knee arthroplasty (TKA) is essential to optimize recovery and satisfaction.1–3 A multimodal pain approach is currently an accepted standard of care to improve pain, enable earlier mobilization and faster recovery, decrease hospital length of stay, and reduce opioid consumption and related side effects.4,5 The multi-modal approach includes perioperative oral and intravenous analgesics, local periarticular injections (PAI), and regional blocks such as femoral or subsartorial saphenous nerve (adductor canal) blocks.2,6,7

Regional nerve blocks are popular in most institutions as part of multimodal pain protocols for immediate postoperative pain control.2,3,6,8 The average duration of regional nerve blocks is 8 to 12 hours for bupivacaine 0.5% and ropivacaine 0.5% or 0.75%.9 Extended-release bupivacaine (Exparel; Pacira Pharmaceuticals, Parsippany, New Jersey) in liposomal form was developed for longer lasting postoperative analgesia.10–14 Although a growing body of literature has supported the prolonged analgesic effectiveness of liposomal bupivacaine in a variety of post-surgical settings, especially as PAI,15–17 some studies have reported controversial results.1,2,11,15,16,18–22

The majority of studies using regional anesthesia focus on femoral nerve block.3,6,23,24 However, femoral nerve blocks are subject to undesired complications such as muscle weakness and falls that often require protective bracing to aid rehabilitation.23,25 There are limited studies analyzing the efficacy of single-injection liposomal bupivacaine in adductor canal block (ACB) in TKA. Because subsartorial saphenous nerve block does not affect posterior capsular pain, the current authors hypothesized that PAI of Exparel would provide better pain relief than a single ACB regional injection.

Materials and Methods

After receiving institutional review board approval, this randomized prospective study was conducted from May 2016 to June 2017. Patients were assigned into 2 cohorts on the day of surgery using randomization software by an independent observer. Randomization was based on age, sex, and body mass index (1:1). Patients with primary knee osteoarthritis undergoing unilateral TKA were included in the study. Exclusion criteria were hypersensitivity or allergies to local anesthetics, prior narcotic use (daily or almost daily use of opioids for >3 months), or previous knee surgery.

All surgeries were performed by a single fellowship-trained surgeon (MM) through a minimally invasive midvastus approach using cemented, posterior-stabilized total knee implants (Triathlon; Stryker, Mahwah, New Jersey). A tourniquet was used only during cementation, which ranged from 5 to 7 minutes. All patents underwent spinal anesthesia with comprehensive preemptive multimodal pain protocol, which included oral celecoxib 400 mg and 1 g intravenous acetaminophen (Ofirmev; Cadence Pharmaceuticals, San Diego, California) 15 mg/kg administered 15 minutes prior to incision.

Primary outcome was the difference in mean pain scores for the first 3 days after surgery. Pain was recorded as patient-reported outcome on a visual analog scale ranging from 0 to 10 at 4 to 12 hours on the day of surgery and on postoperative days 1, 2, and 3 by an orthopedic physician assistant or an orthopedic fellow as the average of the patient's pain during that time line; the physician assistant and fellow were blinded to the study groups. Patients who were discharged prior to postoperative day 3 were contacted via telephone and asked about their pain scores and narcotic consumption.

Secondary outcome was the difference in mean opioid consumption for the first 3 days after surgery. Postoperative analgesia regimen included oral celecoxib (200 mg twice daily), oral gabapentin (300 mg 3 times daily), and narcotics as needed (oral or intravenous opioids). All opioids administered were converted to morphine equivalents.26 Patients were randomized into either the ACB or the PAI group. All patients underwent follow-up for a minimum of 3 months.

Periarticular Injection Protocol

The PAI was a combination of Exparel 266 mg (20 mL vial) with 20 mL of 0.5% bupivacaine hydrochloride and normal saline to a total volume of 120 mL. The injection was administered before and after cementation in the posterior capsule, posteromedial structures, periarticular synovium, extensor apparatus, pes anserinus, anteromedial capsule, periosteum, iliotibial band, and subcutaneous plane.27 Injections were administered using a 20-mL syringe with a 22-gauge needle. Visible tissue expansion was achieved.28

Adductor Canal Block Protocol

An ultrasound-guided injection of the subsartorial saphenous nerve with Exparel 266 mg (20-cc vial) using a 21-gauge, 4-inch Stimuplex A needle (B. Braun Medical Inc, Melsungen, Germany) was performed with a high-frequency linear ultrasound transducer.29 All regional anesthesia was administered by a trained anesthesiologist. Ultrasound (pre- and postinjection) was obtained to verify proper local anesthetic placement.

Statistical Analysis

The authors hypothesized pain scores and morphine consumption would be higher in the ACB group. Sample size analysis for a randomized prospective trial was performed to achieve an 80% power to detect a 20% difference in pain scores (a 2-point score difference on a visual analog scale ranging from 0 to 10 was deemed clinically relevant). A total of 107 primary TKAs were assessed for eligibility; 27 were excluded for not meeting the eligibility criteria. Thirty-five patients were included in final analysis in each group with an allocation ratio of 1:1 (total of 70 patients; Table 1). Prior to surgery, an e-mail stating each patient's group assignment was sent from the pharmacy department to the anesthesiologist and the surgeon. All statistical analyses were performed using SPSS version 21 software (IBM, Armonk, New York). P<.05 was considered significant.

Patient Demographics

Table 1:

Patient Demographics

Results

The mean patient age was 64.2±9.8 years (range, 43.8–88.9 years), and the mean body mass index (BMI) was 33.9±5.3 kg/m2 (range, 23.8–47.3 kg/ m2). The mean overall length of stay was 1.9±0.8 (range, 0–3); there were 2 outpatient cases, and 21 patients had a 23-hour stay. Overall, 37 patients (52%) were discharged home. There was no difference in age, BMI, or length of stay between the 2 groups (Table 1).

There was no statistical significance between the pain scores during the first 12 hours after surgery and postoperative day 1 between the PAI and ACB groups (5.31 vs 4.26, P=.091). However, the mean pain score on postoperative day 3 increased in the ACB group, whereas the pain score in the PAI group continued to decrease; this difference was statistically significant (4.8 vs 1.83, P=.037; Figure 1). There was no significant difference between the 2 groups in the percentage of patients with mild or severe pain (Table 2).

On postoperative day (POD) 3, the mean pain score increased significantly in the adductor canal block (ACB) group and continued to decrease in the periarticular injection (PAI) group (4.8 vs 1.8; P=.03).

Figure 1:

On postoperative day (POD) 3, the mean pain score increased significantly in the adductor canal block (ACB) group and continued to decrease in the periarticular injection (PAI) group (4.8 vs 1.8; P=.03).

Pain Scoresa

Table 2:

Pain Scores

There was no statistically significant difference between the 2 groups regarding the accumulative daily converted morphine equivalent consumption (MEC) or total consumption (Table 3, Figure 2). No correlation was found between any patient factor (age, sex, BMI, and race) and postoperative pain scores, MEC, or disposition.

Comparative Accumulative Opioid Consumption Based on Converted Morphine Equivalent

Table 3:

Comparative Accumulative Opioid Consumption Based on Converted Morphine Equivalent

Mean accumulative daily converted morphine equivalent consumption (MEC) and total consumption were similar between the 2 groups. Abbreviations: ACB, adductor canal block; PAI, periarticular injection; POD, postoperative day.

Figure 2:

Mean accumulative daily converted morphine equivalent consumption (MEC) and total consumption were similar between the 2 groups. Abbreviations: ACB, adductor canal block; PAI, periarticular injection; POD, postoperative day.

At final follow-up, there were no infections, fractures, or readmissions. Three patients were evaluated in the emergency department: 2 patients for uncontrolled pain (1 patient from each cohort) and 1 patient from the PAI cohort for transient serosanguinous drainage without any sign of infection; none of these patients were admitted.

Discussion

Recent advancements in postoperative analgesics aim to improve effective pain control while using less opioids.10,30 Exparel has been approved by the Food and Drug Administration for single-dose PAI for TKA.12–14 Several studies on the safety and efficacy of Exparel have reported postsurgical analgesia for up to 72 hours.13,14 The results of Exparel for pain control after TKA have been controversial. However, studies on the use of a single-injection ACB of Exparel are limited. The aim of the current study was to compare a single injection of regional ACB with PAI of Exparel.

This study had some limitations. First, the results of ultrasound injections are operative dependent; however, this study included 1 anesthesiologist, who was an expert in regional block. Second, ACB is largely a motor-sparing block that provides pain relief for the anterior and medial aspect of the knee and does not address the posterior capsule. Third, some patients were discharged within 24 hours, and although each patient was contacted by the authors and pain scores and opioid consumption were supervised by visiting nurses, the study still may have been subject to error.

Regional nerve blocks can provide effective pain relief while limiting the side effects associated with oral narcotics.2,3,6,8,31,32 Peripheral nerve blocks that have been used for pain control after TKA usually involve the femoral nerve.8,23,33,34 However, femoral nerve blocks cause decreased quadriceps function in the early postoperative period, which can lead to falls and often require bracing to aid rehabilitation.25 With the advent of ultrasonography, the ACB has a high success rate for postoperative pain control after knee surgery.23,29 Other than the saphenous nerve, ACB may include the vastus medialis nerve, medial femoral cutaneous nerve, and articular branches from the obturator nerve, as well as the medial retinacular nerve.35,36 In a randomized study, Kayupov et al29 reported patients who underwent TKA with continuous ACB had lower pain scores, quicker discharge, better ambulation, and higher patient satisfaction compared with patients who underwent TKA with epidural anesthesia.

Although several published studies regarding Exparel have shown promising results,6,28,37–41 other studies did not find any significant difference in outcomes.15,18,24,42–47 In a double-blinded, randomized controlled Exparel trial, Smith et al48 did not find superior efficacy or lower narcotic consumption compared with the ON-Q bupivacaine pump (I-Flow Corp, Lake Forest, California); their study found only a 0.5 morphine equivalent difference between the 2 groups. In another randomized clinical trial, DeClaire et al42 showed no benefit in the use of liposomal bupivacaine compared with ropivacaine PAI for postoperative pain, mean narcotic use, or length of stay in TKA.

In a multicenter, randomized trial of 119 TKA patients, Barrington et al41 reported improved pain at 6 and 12 hours in the liposomal bupivacaine group compared with the ropivacaine group. Kirkness et al49 reported less use of NSAIDs, earlier ambulation, faster discharge, and lower overall cost in their liposomal bupivacaine PAI group compared with patients who had continuous femoral nerve blockade with bupivacaine. Mont et al,28 in a randomized control study, found significant differences in favor of Exparel regarding the percentage of opioid-free patients, time to first opioid use, and overall opioid consumption.

These variations can be due to infiltration techniques, which have been proven to be crucial, suboptimal volume, partial infiltration, or inappropriate needle use. More importantly, studies have demonstrated the significance of adding bupivacaine for the initial phase bridging of pain.28 The current authors used a standard method, meticulous injection techniques throughout the layers of incision, adequate dosage along with a proper needle to minimize leakage, and a bupivacaine bridge to minimize these variables.7,50

The cost of Exparel is much higher than bupivacaine.27,28,42,50 Kim et al50 conducted a cost analysis of Exparel compared with generic bupivacaine and reported the cost per dose to be $300 vs $3, respectively. Even with such difference in cost, Exparel has led to improved cost effectiveness due to the reduction in length of stay and the lack of complications associated with peripheral nerve blocks, such as nerve injury, risk of falls, temporary loss of motor function, and delayed rehabilitation.28,50 One potential complication of Exparel compared with bupivacaine is a prolonged foot drop if a large amount is infiltrated into the peroneal nerve.

The current authors also found longer pain relief with PAI, although there was no statistical significance for the accumulative daily converted morphine equivalent consumption between the 2 groups during the first 2 days after surgery. Similarly, in a prospective, randomized, double-blind controlled trial, Snyder et al39 reported significant improvement in pain scores and lower opioid consumption with Exparel in PAI. Youm et al51 reported more effective pain control in the PAI group than in the femoral nerve block group during the early (0–8 hours) postoperative period; however, the PAI group experienced rebound pain at 24 hours.

The current study found an increase in pain scores in both groups on postoperative 1; however, a major increase was observed in the ACB group on postoperative day 3 compared with the PAI group. In conclusion, although longer pain relief was observed in the PAI group than in the ACB group using Exparel after TKA during the duration of the current study, other outcomes were similar. The PAI group had lower pain scores on postoperative day 3.

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Patient Demographics

CharacteristicACB GroupPAI GroupP
Sex (female/male), No.29/624/11.26
Age, mean±SD (range), y64.2±10.9 (43.8–88.9)62.6±8.7 (44.1–81.3).49
Body mass index, mean±SD (range), kg/m234.3±5.2 (25.5–46.1)33.6±5.6 (23.8–47.3).59
Length of stay, mean±SD (range), d2.26±0.74 (1–3)1.62±0.82 (0–3).14
Discharged home, No. (%)16 (46)21 (60).81

Pain Scoresa

Time/ValuePain ScoreP

ACB GroupPAI Group
4 to 12 h.129
  Mean±SD3.91±2.343.11±2.03
  Range0–90–8
  95% CI3.1–4.72.4–3.8
Postoperative day 1.091
  Mean±SD5.31±2.794.26±2.31
  Range0–100–10
  95% CI4.4–6.23.5–5.0
Postoperative day 2.418
  Mean±SD3.26±1.722.94±1.64
  Range0–80–7
  95% CI2.7–3.82.4–3.5
Postoperative day 3.037
  Mean±SD4.83±3.081.83±1.47
  Range0–80–7
  95% CI3.8–5.81.4–2.3

Comparative Accumulative Opioid Consumption Based on Converted Morphine Equivalent

Time/ValueMorphine Equivalent Consumption, mgP

ACB GroupPAI Group
4 to 12 h.221
  Mean±SD24.39±36.916.46±9.2
  Range0–2160–31
  95% CI12.2–36.613.4–19.5
Postoperative day 1.642
  Mean±SD46.57±18.244.63±16.7
  Range7.5–777.5–75
  95% CI40.6–52.539.2–50.2
Postoperative day 2.521
  Mean±SD39.16±16.836.57±16.8
  Range12–757.5–75
  95% CI33.6–44.731.1–42.1
Postoperative day 3.754
  Mean±SD37.4±17.936.2±13.8
  Range7.5–757.5–60
  95% CI31.5–43.431.7–40.8
Total.242
  Mean±SD135.2±54.8121.8±38.4
  Range35–33627–175
  95% CI117–153.3109–134.5
Authors

The authors are from the Department of Orthopaedic Surgery (MM), NYU Langone Orthopedic Hospital, and the Department of Orthopaedic Surgery (IHK), BronxCare Hospital Center (SB, VHS), Bronx, New York.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Morteza Meftah, MD, Department of Orthopaedic Surgery, NYU Langone Orthopedic Hospital, 301 E 17th St, 15th Fl, New York, NY 10003 ( Morteza.Meftah@nyulangone.org).

Received: August 09, 2018
Accepted: November 16, 2018
Posted Online: November 26, 2019

10.3928/01477447-20191122-05

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