Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02762071
• Collaborator: University of Texas Southwestern Medical Center (Other)
• Enrollment: 108
• Locations: 2
• Arms: 2
• Duration (Months): 36.4
• Patients Per Site: 54
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Arthropathy; Shoulder Pain; Closed Fracture Proximal Humerus, Four Part	Drug: Liposomal bupivacaine; Drug: Interscalene Nerve Block	N/A

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Apr 15, 2019
• Actual Study Completion Date: Apr 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: Liposomal Bupivacaine Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.	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

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale Pain Score at 24 Hours Postoperatively [At 24 hours after surgery]

   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).

Secondary Outcome Measures

1. Opioid Medication Consumption in Morphine Milligram Equivalents [Up to 4 days postoperatively]

   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.

2. Length of Hospital Stay [At the time of discharge from hospital, Up to 4 days]

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

3. Postoperative Visual Analog Scale (VAS) Pain Scores [Up to first postoperative visit, maximum 30 days]

   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).

4. Patient Satisfaction With Pain Management [At first postoperative visit, up to 30 days]

   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).

5. Length of Stay in the Post-anesthesia Care Unit (PACU) [At the time of discharge from PACU, Up to 1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Columbia	Maryland	United States	21044
2	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Johns Hopkins University
• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Uma Srikumaran, MD, MBA, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 23, 2016

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02762071
• Other Study ID Numbers: IRB00063657
• First Posted: May 4, 2016
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Shoulder Pain; Fractures, Closed; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
Period Title: Overall Study
STARTED	54	54
COMPLETED	54	54
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine	Total
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.	Total of all reporting groups
Overall Participants	54	54	108
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 31.5%	24 44.4%	41 38%
>=65 years	37 68.5%	30 55.6%	67 62%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (10)	65 (9)	67 (9)
Sex: Female, Male (Count of Participants)
Female	24 44.4%	23 42.6%	47 43.5%
Male	30 55.6%	31 57.4%	61 56.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 9.3%	2 3.7%	7 6.5%
Not Hispanic or Latino	49 90.7%	52 96.3%	101 93.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 1.9%	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 14.8%	13 24.1%	21 19.4%
White	46 85.2%	40 74.1%	86 79.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	54 100%	54 100%	108 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale Pain Score at 24 Hours Postoperatively
Description	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).
Time Frame	At 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Measure Participants	54	54
Mean (Standard Deviation) [score on a scale]	5.0 (3.0)	4.9 (2.7)

2. Secondary Outcome

Title	Opioid Medication Consumption in Morphine Milligram Equivalents
Description	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.
Time Frame	Up to 4 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Measure Participants	54	54
Total Intraoperative + Postoperative day 1	38 (14)	60 (51)
Intraoperative	21 (11)	25 (14)
Postoperative day 1	18 (12)	36 (48)
Postoperative day 2	9 (10)	7 (8)
Postoperative day 3	3 (6)	4 (8)
Postoperative day 4	2 (6)	2 (5)

3. Secondary Outcome

Title	Length of Hospital Stay
Description	Duration of stay in hospital (hours) after shoulder replacement surgery.
Time Frame	At the time of discharge from hospital, Up to 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Measure Participants	54	54
Mean (Standard Deviation) [hours]	39 (20)	36 (14)

4. Secondary Outcome

Title	Postoperative Visual Analog Scale (VAS) Pain Scores
Description	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).
Time Frame	Up to first postoperative visit, maximum 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
Measure Participants	54	54
6 hours postoperative	2.9 (3.1)	5.1 (2.9)
12 hours postoperative	4.0 (3.1)	4.6 (3.0)
18 hours postoperative	5.2 (3.4)	4.6 (3.1)
30 hours postoperative	4.8 (2.9)	4.6 (2.7)
36 hours postoperative	4.1 (2.9)	5.1 (2.2)
42 hours postoperative	4.0 (2.8)	4.6 (2.8)
48 hours postoperative	4.2 (2.8)	4.3 (2.7)
54 hours postoperative	4.2 (2.7)	4.4 (2.5)
60 hours postoperative	4.1 (2.6)	3.9 (2.1)
66 hours postoperative	3.8 (2.6)	3.6 (2.2)
72 hours postoperative	3.8 (2.6)	3.7 (2.6)
78 hours postoperative	4.0 (2.4)	4.2 (2.6)
84 hours postoperative	4.0 (2.7)	4.1 (2.6)
90 hours postoperative	3.9 (2.5)	4.1 (2.5)
96 hours postoperative	3.8 (2.4)	4.3 (2.8)
1st postoperative visit	3.4 (2.6)	4.4 (2.5)

5. Secondary Outcome

Title	Patient Satisfaction With Pain Management
Description	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).
Time Frame	At first postoperative visit, up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
Measure Participants	54	54
Satisfaction with pain management in the hospital	8.4 (2.6)	7.8 (3.1)
Satisfaction with pain management at home	8.7 (1.9)	8.1 (2.7)

6. Secondary Outcome

Title	Length of Stay in the Post-anesthesia Care Unit (PACU)
Description	Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.
Time Frame	At the time of discharge from PACU, Up to 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interscalene Nerve Block	Liposomal Bupivacaine
Arm/Group Description	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: 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.	Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon.
Measure Participants	54	54
Mean (Standard Deviation) [minutes]	102 (53)	139 (77)

Adverse Events

Time Frame	1 month
Arm/Group Title	Interscalene Nerve Block		Liposomal Bupivacaine
Arm/Group Description	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: 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.		Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
All Cause Mortality
	Interscalene Nerve Block		Liposomal Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)
Serious Adverse Events
	Interscalene Nerve Block		Liposomal Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	Interscalene Nerve Block		Liposomal Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.