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Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

Primary Purpose

Shoulder Pain, Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine liposome
Bupivacaine Hydrochloride
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring peripheral nerve block, interscalene, arthroscopic shoulder surgery, liposomal bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medically optimized patients that will undergo an elective surgery for arthroscopic shoulder surgery

Exclusion Criteria:

  • under 18 years pregnant or breast-feeding, non-English speaking, have renal or hepatic dysfunction, history of chronic opioid use, receiving worker's compensation, smoker, receiving capsular release, respiratory compromise or BMI < 18 or > 35 or allergy to local anesthetics or opioids

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine

Liposomal bupivacaine

Arm Description

Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine.

Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.

Outcomes

Primary Outcome Measures

Average worst pain score with movement over 3 days
The investigators will assess the patients worst pain score each day with movement up to 3 days post-operative. Pain will be assessed using the visual analog scale (VAS) with 0 indicating no pain and 10 indicating worst pain.

Secondary Outcome Measures

Average worst pain score with movement over 7 days
The investigators will assess the patients worst pain score each day with movement up to 7 days post-operative. Pain will be assessed using the visual analog scale (VAS) with 0 indicating no pain and 10 indicating worst pain.
Total opioid use over 3 days
The investigators will calculate opioid use by recording opioid consumption from patient responses. The total consumption will be converted to morphine equivalents.
Total opioid use over 7 days
The investigators will calculate opioid use by recording opioid consumption from patient responses. The total consumption will be converted to morphine equivalents.
Functional Assessment with Physical Therapy
Physical therapy function will be assessed using the Shoulder Function Classification System (SFCS). Patients will receive a score between 0 (poor functional status) - 100 (full function).
Risk of persistent post-operative pain at 6 months & 12 months
Patients will be interviewed with the Brief Pain Inventory (BPI) at 6 and 12 months post-operative to assess persistent pain.
Adverse events
This includes nausea/vomiting, nerve injury, local anesthetic toxicity, unexpected readmission or emergency room visit

Full Information

First Posted
August 8, 2018
Last Updated
September 27, 2021
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03638960
Brief Title
Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Official Title
Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will be comparing pain scores and opioid use in patients receiving interscalene peripheral blocks with plain bupivacaine versus those receiving liposomal bupivacaine. Liposomal bupivacaine is described as releasing local anesthetic up to 72 hours after its injection; therefore if liposomal bupivacaine can provide extended pain relief compared to plain bupivacaine, the investigators can consider using it as our primary local anesthetic. As secondary outcomes, the investigators will also be looking at difference in functional status and long-term differences between the two local anesthetics.
Detailed Description
Background: The current standard of care for patients at the investigators' institution is to perform an interscalene peripheral nerve block for patients receiving arthroscopic shoulder surgery surgery as it is an effective opioid-free alternative for post-operative pain control. The investigators in the past perform both single shot injections and place catheter based on patient and surgical preferences. Catheters have shown to have extended benefit throughout the perioperative period, including lower pain scores, reduced analgesics and improved sleep. However, the negatives of catheters include the placement of a foreign body, increased time to perform the procedure, interference in surgical field and increased cost of catheter equipment and local anesthetic pump and premature catheter dislodgement. Therefore, pros and cons of deciding between placing a single shot injecting versus catheter has to be considered individually for each case. Liposomal bupivacaine due to its liposomal outer layers, releases bupivacaine over a longer period of time than plain bupivacaine. A pharmacokinetic study showed the terminal half-life of bupivacaine to be 131 ± 58 minutes versus 1294 ± 860 minutes for liposomal bupivacaine. In a recent study comparing liposomal bupivacaine to placebo for interscalene peripheral nerve blocks, patients receiving liposomal bupivacaine had significantly lower pain scores over 48 hours and received less opioid over 72 hours[6]. Therefore, if a single shot injection with liposomal bupivacaine can provide longer pain relief than plain bupivacaine, it makes the decision to perform single shot interscalene peripheral nerve blocks easier. Study Objectives The investigators would like to study whether an interscalene peripheral block injection with liposomal bupivacaine provides superior pain control compared to an interscalene single shot with plain bupivacaine. The investigators will be looking at average daily pain scores, highest daily visual analog scale (VAS) pain scores at rest and with movement, total daily opioid consumption from immediately post-operative to 7 days post-operative, and functionality with physical therapy. The investigators will also plan to follow these patients 6 month and 12 months post-operative to determine whether there is any difference in incidence of persistent post-operative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Postoperative Pain
Keywords
peripheral nerve block, interscalene, arthroscopic shoulder surgery, liposomal bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The investigators plan to perform a double blinded randomized control study. Patients will be randomly assigned to either group A or group B. Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine. Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.
Masking
ParticipantOutcomes Assessor
Masking Description
The participants and data collectors are unaware of which group the patient belongs to. The anesthesiologist performing the nerve block will not be blinded.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine.
Arm Title
Liposomal bupivacaine
Arm Type
Experimental
Arm Description
Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome
Other Intervention Name(s)
peripheral nerve block
Intervention Description
The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either liposomal bupivacaine prior to the patient receiving surgery.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
peripheral nerve block
Intervention Description
The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either plain bupivacaine prior to the patient receiving surgery.
Primary Outcome Measure Information:
Title
Average worst pain score with movement over 3 days
Description
The investigators will assess the patients worst pain score each day with movement up to 3 days post-operative. Pain will be assessed using the visual analog scale (VAS) with 0 indicating no pain and 10 indicating worst pain.
Time Frame
3 days post-operative
Secondary Outcome Measure Information:
Title
Average worst pain score with movement over 7 days
Description
The investigators will assess the patients worst pain score each day with movement up to 7 days post-operative. Pain will be assessed using the visual analog scale (VAS) with 0 indicating no pain and 10 indicating worst pain.
Time Frame
7 days post-operative
Title
Total opioid use over 3 days
Description
The investigators will calculate opioid use by recording opioid consumption from patient responses. The total consumption will be converted to morphine equivalents.
Time Frame
3 days post-operative
Title
Total opioid use over 7 days
Description
The investigators will calculate opioid use by recording opioid consumption from patient responses. The total consumption will be converted to morphine equivalents.
Time Frame
7 days post-operative
Title
Functional Assessment with Physical Therapy
Description
Physical therapy function will be assessed using the Shoulder Function Classification System (SFCS). Patients will receive a score between 0 (poor functional status) - 100 (full function).
Time Frame
Up to 1 month post-operative
Title
Risk of persistent post-operative pain at 6 months & 12 months
Description
Patients will be interviewed with the Brief Pain Inventory (BPI) at 6 and 12 months post-operative to assess persistent pain.
Time Frame
6 months, 12 months
Title
Adverse events
Description
This includes nausea/vomiting, nerve injury, local anesthetic toxicity, unexpected readmission or emergency room visit
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medically optimized patients that will undergo an elective surgery for arthroscopic shoulder surgery Exclusion Criteria: under 18 years pregnant or breast-feeding, non-English speaking, have renal or hepatic dysfunction, history of chronic opioid use, receiving worker's compensation, smoker, receiving capsular release, respiratory compromise or BMI < 18 or > 35 or allergy to local anesthetics or opioids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beamy S Sharma, M.D., M.B.A.
Phone
5108255954
Email
beamy.sharma@gmail.com
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beamy S Sharma
First Name & Middle Initial & Last Name & Degree
Gligor Gucev, M.D.
First Name & Middle Initial & Last Name & Degree
Rana Movahedi, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23108685
Citation
Cho CH, Song KS, Min BW, Jung GH, Lee YK, Shin HK. Efficacy of interscalene block combined with multimodal pain control for postoperative analgesia after rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):542-7. doi: 10.1007/s00167-012-2272-3. Epub 2012 Oct 30.
Results Reference
background
PubMed Identifier
27988164
Citation
Liu XN, Noh YM, Yang CJ, Kim JU, Chung MH, Noh KC. Effects of a Single-Dose Interscalene Block on Pain and Stress Biomarkers in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2017 May;33(5):918-926. doi: 10.1016/j.arthro.2016.09.018. Epub 2016 Dec 14.
Results Reference
background
PubMed Identifier
24257398
Citation
Salviz EA, Xu D, Frulla A, Kwofie K, Shastri U, Chen J, Shariat AN, Littwin S, Lin E, Choi J, Hobeika P, Hadzic A. Continuous interscalene block in patients having outpatient rotator cuff repair surgery: a prospective randomized trial. Anesth Analg. 2013 Dec;117(6):1485-92. doi: 10.1213/01.ane.0000436607.40643.0a.
Results Reference
background
PubMed Identifier
27107906
Citation
Malik T, Mass D, Cohn S. Postoperative Analgesia in a Prolonged Continuous Interscalene Block Versus Single-Shot Block in Outpatient Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study. Arthroscopy. 2016 Aug;32(8):1544-1550.e1. doi: 10.1016/j.arthro.2016.01.044. Epub 2016 Apr 20.
Results Reference
background
PubMed Identifier
20357145
Citation
Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.
Results Reference
background
PubMed Identifier
15322437
Citation
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004 Sep-Oct;20(5):309-18. doi: 10.1097/00002508-200409000-00005.
Results Reference
background
Citation
Pacira Pharmaceuticals, I., Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery. 2016.
Results Reference
background

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Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

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