Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03845894

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Arthroplasty	Drug: Liposomal bupivacaine Drug: Bupivacaine with adjuvants	Phase 4

Detailed Description

The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty

Actual Study Start Date :

Mar 3, 2020

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liposomal Bupivacaine ISB	Drug: Liposomal bupivacaine Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
Active Comparator: Bupivacaine with adjuvants ISB	Drug: Bupivacaine with adjuvants Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Arm

Intervention/Treatment

Active Comparator: Liposomal Bupivacaine ISB

Drug: Liposomal bupivacaine

Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)

Active Comparator: Bupivacaine with adjuvants ISB

Drug: Bupivacaine with adjuvants

Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Outcome Measures

Primary Outcome Measures

Area-under-the-curve (AUC) of average pain scores for the first 48 hours [Up to 48 hours postoperatively]
Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.

Secondary Outcome Measures

Average pain score at 48 hours [at 48 hours]
Pain levels will be measured by the mean VAS-NRS. The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.
Postoperative opioid consumption for the first 48 hours [Up to 48 hours]
Opioid consumption will be reported as the mean in PO oxycodone equivalents
Satisfaction with surgical experience [At 48 hours]
Satisfaction levels will be measured by questionnaire on a5 point Likert scale with 1 (Strong Disagree) to 5 (Strongly Agree). Higher scores denote better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All patients undergoing total shoulder arthroplasty (not a reverse)
Age ≥ 18 years
Ability to understand and the willingness to sign an IRB-approved informed consent document.
ASA patient status I-III patients
Weight Greater than or equal to 50 kg

Exclusion Criteria:

Contraindications to an interscalene block or phrenic blockade
Infection at injection site
Pre-existing neurological dysfunction affecting the operative extremity
Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of long-acting opioids
BMI >40
Uncontrolled diabetes (A1c >8.0)
Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery
Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)
Patients who are wards of the state
History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
Patients with moderate-severe hepatic or renal impairment