Oral Duloxetine as a Premedication for Postoperative Pain Control

Ain Shams University70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Anesthesia

Interventions

Duloxetine 60mgDRUG

Duloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation

PlaceboDRUG

placebo tablets identical to duloxetine tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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. 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).

Locations (1)

faculty of medicine, Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Assess the onset of spinal anesthesia

Time to T10 sensory block and time to Bromage 1 motor block

Time frame: 20 min

Secondary Outcomes

Duration of spinal anesthesia

Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery

Time frame: 4 hours

Postoperative pain

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 frame: 24 hours

Time for first postoperative rescue analgesia request, frequency, and total morphine consumption

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

Time frame: 24 hours

Data from ClinicalTrials.gov

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