Comparative Study of Acute and Early Pain in Open Surgical Repair of Shoulder Rotator Cuff between Baclofen, Oral Acetaminophen and Combination of them

Phase 2

• Conditions: Shoulder rotator cuff.; Unspecified rotator cuff tear or rupture of unspecified shoulder, not specified as traumatic; M75.100

• Registration Number: IRCT20141009019470N93
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Patients candidate for Repair of Shoulder Rotator Cuff
Age 18-65 years
(ASA) I, II

Exclusion Criteria

Allergy to the acetaminophen and baclofen
History of uncontrolled hypertension
Cardiac Disease
Liver and kidney problems
Hormonal problems
A history of acute or chronic pain
Digestive problems
Sexual disorders
Heavy smoking
CNS Depression
alcohol consumption
Corticosteroid intake
Benzodiazepine recipients
Pregnancy
Revision cases
Neuropathy
Uncontrolled diabetes

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain. Timepoint: 6, 12, 24, 48 hours postoperatively, one week, ten days and two weeks after surgery. Method of measurement: Numerical Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption. Timepoint: Discharge from recovery. Method of measurement: Observation.;Patient satisfaction. Timepoint: Two weeks after surgery. Method of measurement: Likert.