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Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair

NCT05800847 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-04-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.

Conditions

  • Rotator Cuff Tears

Interventions

DRUG

Gabapentin

Gabapentin will be administered for 2 days at 100 mg q8h for titration to avoid side effects. The next 12 days, gabapentin will be taken at 300 mg q8h.

DRUG

Placebo

Placebo will follow the same dosing pattern as gabapentin to allow for blinding. Placebo will be encapsulated with a gelatin capsule to mimic the look of gabapentin.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Hughston Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2024-04-30
Completion
2024-07-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05800847 on ClinicalTrials.gov