Oral Duloxetine as a Premedication for Postoperative Pain Control

Anesthesia Clinical Trial

Official title:

"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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050656
• Other study ID #: FMASU R 63/ 2021
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: July 29, 2021

Study information

• Verified date: September 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 29, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative

Intervention

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
placebo tablets identical to duloxetine tablets

Locations

Country	Name	City	State
Egypt	faculty of medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the onset of spinal anesthesia	Time to T10 sensory block and time to Bromage 1 motor block	20 min
Secondary	Duration of spinal anesthesia	Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery	4 hours
Secondary	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
Secondary	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