Title

Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    bupivacaine ...
  • Study Participants

    108
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.
After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. Consent will be completed after explanation of each treatment group and the data to be collected. Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site.

The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.

The primary outcome is pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). Secondary outcomes are postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 hours; VAS pain score at the first postoperative visit ; intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the post-anesthesia care unit (PACU); duration of hospital stay; and VAS score for satisfaction with pain control in the hospital and at home, assessed at participants' first postoperative visit. VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
Study Started
Apr 30
2016
Primary Completion
Apr 15
2019
Study Completion
Apr 15
2019
Results Posted
Mar 30
2020
Last Update
Mar 30
2020

Drug Liposomal bupivacaine

Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.

  • Other names: Exparel

Drug Interscalene Nerve Block

Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.

Interscalene Nerve Block Active Comparator

Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.

Liposomal Bupivacaine Experimental

Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.

Criteria

Inclusion Criteria:

Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.

Exclusion Criteria:

Allergy to liposomal bupivacaine
Contraindications to the interscalene nerve block such as:
Preexisting neurologic defects
Local anesthetic allergy
Coagulopathy
Contralateral phrenic nerve dysfunction
Severe chronic obstructive pulmonary disease

Summary

Interscalene Nerve Block

Liposomal Bupivacaine

All Events

Event Type Organ System Event Term

Visual Analog Scale Pain Score at 24 Hours Postoperatively

The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).

Interscalene Nerve Block

5.0
score on a scale (Mean)
Standard Deviation: 3.0

Liposomal Bupivacaine

4.9
score on a scale (Mean)
Standard Deviation: 2.7

Opioid Medication Consumption in Morphine Milligram Equivalents

We analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents.

Interscalene Nerve Block

Intraoperative

21.0
morphine milligram equivalents (Mean)
Standard Deviation: 11

Postoperative day 1

18.0
morphine milligram equivalents (Mean)
Standard Deviation: 12

Postoperative day 2

9.0
morphine milligram equivalents (Mean)
Standard Deviation: 10

Postoperative day 3

3.0
morphine milligram equivalents (Mean)
Standard Deviation: 6

Postoperative day 4

2.0
morphine milligram equivalents (Mean)
Standard Deviation: 6

Total Intraoperative + Postoperative day 1

38.0
morphine milligram equivalents (Mean)
Standard Deviation: 14

Liposomal Bupivacaine

Intraoperative

25.0
morphine milligram equivalents (Mean)
Standard Deviation: 14

Postoperative day 1

36.0
morphine milligram equivalents (Mean)
Standard Deviation: 48

Postoperative day 2

7.0
morphine milligram equivalents (Mean)
Standard Deviation: 8

Postoperative day 3

4.0
morphine milligram equivalents (Mean)
Standard Deviation: 8

Postoperative day 4

2.0
morphine milligram equivalents (Mean)
Standard Deviation: 5

Total Intraoperative + Postoperative day 1

60.0
morphine milligram equivalents (Mean)
Standard Deviation: 51

Length of Hospital Stay

Duration of stay in hospital (hours) after shoulder replacement surgery.

Interscalene Nerve Block

39.0
hours (Mean)
Standard Deviation: 20

Liposomal Bupivacaine

36.0
hours (Mean)
Standard Deviation: 14

Postoperative Visual Analog Scale (VAS) Pain Scores

We analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).

Interscalene Nerve Block

12 hours postoperative

4.0
score on a scale (Mean)
Standard Deviation: 3.1

18 hours postoperative

5.2
score on a scale (Mean)
Standard Deviation: 3.4

1st postoperative visit

3.4
score on a scale (Mean)
Standard Deviation: 2.6

30 hours postoperative

4.8
score on a scale (Mean)
Standard Deviation: 2.9

36 hours postoperative

4.1
score on a scale (Mean)
Standard Deviation: 2.9

42 hours postoperative

4.0
score on a scale (Mean)
Standard Deviation: 2.8

48 hours postoperative

4.2
score on a scale (Mean)
Standard Deviation: 2.8

54 hours postoperative

4.2
score on a scale (Mean)
Standard Deviation: 2.7

60 hours postoperative

4.1
score on a scale (Mean)
Standard Deviation: 2.6

66 hours postoperative

3.8
score on a scale (Mean)
Standard Deviation: 2.6

6 hours postoperative

2.9
score on a scale (Mean)
Standard Deviation: 3.1

72 hours postoperative

3.8
score on a scale (Mean)
Standard Deviation: 2.6

78 hours postoperative

4.0
score on a scale (Mean)
Standard Deviation: 2.4

84 hours postoperative

4.0
score on a scale (Mean)
Standard Deviation: 2.7

90 hours postoperative

3.9
score on a scale (Mean)
Standard Deviation: 2.5

96 hours postoperative

3.8
score on a scale (Mean)
Standard Deviation: 2.4

Liposomal Bupivacaine

12 hours postoperative

4.6
score on a scale (Mean)
Standard Deviation: 3.0

18 hours postoperative

4.6
score on a scale (Mean)
Standard Deviation: 3.1

1st postoperative visit

4.4
score on a scale (Mean)
Standard Deviation: 2.5

30 hours postoperative

4.6
score on a scale (Mean)
Standard Deviation: 2.7

36 hours postoperative

5.1
score on a scale (Mean)
Standard Deviation: 2.2

42 hours postoperative

4.6
score on a scale (Mean)
Standard Deviation: 2.8

48 hours postoperative

4.3
score on a scale (Mean)
Standard Deviation: 2.7

54 hours postoperative

4.4
score on a scale (Mean)
Standard Deviation: 2.5

60 hours postoperative

3.9
score on a scale (Mean)
Standard Deviation: 2.1

66 hours postoperative

3.6
score on a scale (Mean)
Standard Deviation: 2.2

6 hours postoperative

5.1
score on a scale (Mean)
Standard Deviation: 2.9

72 hours postoperative

3.7
score on a scale (Mean)
Standard Deviation: 2.6

78 hours postoperative

4.2
score on a scale (Mean)
Standard Deviation: 2.6

84 hours postoperative

4.1
score on a scale (Mean)
Standard Deviation: 2.6

90 hours postoperative

4.1
score on a scale (Mean)
Standard Deviation: 2.5

96 hours postoperative

4.3
score on a scale (Mean)
Standard Deviation: 2.8

Patient Satisfaction With Pain Management

Visual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).

Interscalene Nerve Block

Satisfaction with pain management at home

8.7
score on a scale (Mean)
Standard Deviation: 1.9

Satisfaction with pain management in the hospital

8.4
score on a scale (Mean)
Standard Deviation: 2.6

Liposomal Bupivacaine

Satisfaction with pain management at home

8.1
score on a scale (Mean)
Standard Deviation: 2.7

Satisfaction with pain management in the hospital

7.8
score on a scale (Mean)
Standard Deviation: 3.1

Length of Stay in the Post-anesthesia Care Unit (PACU)

Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.

Interscalene Nerve Block

102.0
minutes (Mean)
Standard Deviation: 53

Liposomal Bupivacaine

139.0
minutes (Mean)
Standard Deviation: 77

Total

108
Participants

Age, Continuous

67
years (Mean)
Standard Deviation: 9

Age, Categorical

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Interscalene Nerve Block

Liposomal Bupivacaine