Oral Duloxetine as a Premedication for Postoperative Pain Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair? a Prospective, Randomized, Double-blind Controlled Trial

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Duloxetine 60mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group D (duloxetine group)<br>Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. | Drug: Duloxetine 60mg<br>* 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<br>|
| Placebo Comparator: Group C (control group)<br>Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. | Drug: Placebo<br>* placebo tablets identical to duloxetine tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the onset of spinal anesthesia | Time to T10 sensory block and time to Bromage 1 motor block | 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of spinal anesthesia | Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery | 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. | 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 | 24 hours |