Oral Duloxetine as a Premedication for Postoperative Pain Control

"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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Duloxetine 60mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: tamer abdelaziz, MD, Faculty of medicine, Ain Shams University, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: FMASU R 63/ 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No