Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05005260

Collaborator

(none)

Enrollment

Location

Arms

20.5

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Brachial Plexus Block	Drug: Bupivacaine HCl Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Unblinded

Primary Purpose:

Treatment

Official Title:

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

Actual Study Start Date :

Oct 14, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: liposomal bupivacaine single-shot interscalene blockade Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine	Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
Active Comparator: continuous interscalene nerve blockade Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.	Drug: Bupivacaine HCl Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.

Arm

Intervention/Treatment

Active Comparator: liposomal bupivacaine single-shot interscalene blockade

Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj

Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).

Active Comparator: continuous interscalene nerve blockade

Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Drug: Bupivacaine HCl

Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.

Outcome Measures

Primary Outcome Measures

Change in pain intensity scores [Post-Operative Day 1]
Self-reported pain intensity scores measure using pain scores of 0 (no pain) to 10 (worst pain imaginable)
Opioid consumption [Post-Operative Day 1]
Reported in mg oral morphine equivalents (OME)

Secondary Outcome Measures

Quality of recovery score (QoR) [up to post-operative day 7]
15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Overall benefit of analgesic score (OBAS) [up to post-operative day 7]
Patient survey assessing patient experience with postoperative pain regimen. 7 question scoring system entails a combination of pain intensity, adverse opioid events, and patient satisfaction. The total OBAS score is calculated via 'sum items Q1 through Q6 and add [4 - score from Q7].' This score consists of a 29-point scale ranging from 0 (best) to 28 (worst); therefore, lower OBAS scores indicate more analgesic benefit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
Patients 18 years of age and older
Able to provide informed consent for him or herself

Exclusion Criteria

Chronic pain syndromes
Chronic opioid use (>1 month) with OME >5 mg/day OR acute opioid use (< 1 month) with OME > 30 mg/day.
Body mass index (BMI) > 45 kg/m2
Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. *defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
Personal or family history of malignant hyperthermia.
Major systemic medical problems such as:
Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 93% on room air.
History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).

o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.

Known to be currently pregnant or actively breastfeeding++

o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)