Oral Duloxetine as a Premedication for Postoperative Pain Control

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Duloxetine 60mg; Drug: Placebo

• Registration Number: NCT05050656
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.

Detailed Description

We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.

Study Timeline

• Study Start: 2021-03-15
• Primary Completion: 2021-07-28
• Study Completion: 2021-07-29
• Status Verified: 2021-09
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-20
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• American Society of Anesthesiologists I or II.
• Sex: Both sexes.
• Age between 18 and 50.
• Height 155-180 cm.
• Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.

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Exclusion Criteria

• Declining to give written informed consent.
• History of allergy to the medications used in the study.
• Had a history of drug or alcohol abuse.
• Taking opioids or sedative medications.
• Inability to communicate with patients to evaluate the postoperative pain.
• Need for postoperative ICU hospitalization.
• Hepatic or renal failure.
• Patients with a history of taking duloxetine or any SSRIs.
• Contraindications to regional anesthesia (including coagulopathy and local infection).
• Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
• Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
• Quinolones (ciprofloxacin).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D (duloxetine group)	Duloxetine 60mg	Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.
Group C (control group)	Placebo	Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.

Primary Outcome Measures

Name	Time	Method
Assess the onset of spinal anesthesia	20 min	Time to T10 sensory block and time to Bromage 1 motor block

Secondary Outcome Measures

Name	Time	Method
Duration of spinal anesthesia	4 hours	Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery
Postoperative pain	24 hours	Will be assessed by the patient using the visual analog scale (VAS, 0=no pain; 10=worst possible pain) every 4hrs up to 24hrs after the operation.
Time for first postoperative rescue analgesia request, frequency, and total morphine consumption	24 hours	All participants will receive intravenous paracetamol, one gram every 8hrs, VAS score of 4 or more will receive 3 mg morphine intravenously and not be repeated more frequently than 4hrs limited to 12 mg morphine per 24hrs after operation

Trial Locations

Locations (1)

faculty of medicine, Ain Shams University; 🇪🇬 Cairo, Egypt