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

Sponsor

University of Southern California (Other)

Overall Status

Recruiting

CT.gov ID

NCT03638960

Collaborator

(none)

Enrollment

Location

Arms

63.3

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain Postoperative Pain	Drug: Bupivacaine liposome Drug: Bupivacaine Hydrochloride	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 21, 2019

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine.	Drug: Bupivacaine Hydrochloride The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either plain bupivacaine prior to the patient receiving surgery. Other Names: peripheral nerve block
Experimental: Liposomal bupivacaine Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.	Drug: Bupivacaine liposome The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either liposomal bupivacaine prior to the patient receiving surgery. Other Names: peripheral nerve block

Arm

Intervention/Treatment

Active Comparator: Bupivacaine

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

Drug: Bupivacaine Hydrochloride

The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either plain bupivacaine prior to the patient receiving surgery.

Other Names:

peripheral nerve block

Experimental: Liposomal bupivacaine

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

Drug: Bupivacaine liposome

The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either liposomal bupivacaine prior to the patient receiving surgery.

Other Names:

peripheral nerve block

Outcome Measures

Primary Outcome Measures

Average worst pain score with movement over 3 days [3 days post-operative]
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 [7 days post-operative]
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 [3 days post-operative]
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 [7 days post-operative]
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 [Up to 1 month post-operative]
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 [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 [7 days]
This includes nausea/vomiting, nerve injury, local anesthetic toxicity, unexpected readmission or emergency room visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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