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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141009019470N93
Enrollment
66
Registered
2020-01-08
Start date
2020-02-04
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder rotator cuff. Unspecified rotator cuff tear or rupture of unspecified shoulder, not specified as traumatic

Interventions

Intervention 1: Intervention group:Patients in the first intervention group received 500 mg of acetaminophen 6 hours after surgery and one placebo tablet similar to baclofen every 2 hours for 2 weeks.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Emadi

Shiraz University of Medical Sciences

mahsaemadi@yahoo.com+98 71 3647 4270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026