Oral Duloxetine as a Premedication for Postoperative Pain Control

NCT05050656 | Completed Phase 4

• 1 other identifier: FMASU R 63/ 2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Assess the onset of spinal anesthesia

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

  20 min

Secondary Outcomes (3)

• Duration of spinal anesthesia

  4 hours

• Postoperative pain

  24 hours

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

  24 hours

Study Arms (2)

Group D (duloxetine group)

ACTIVE COMPARATOR

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

Group C (control group)

PLACEBO COMPARATOR

Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.

Drug: Placebo

Interventions

Duloxetine 60mg DRUG

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

Group D (duloxetine group)

Placebo DRUG

placebo tablets identical to duloxetine tablets

Group C (control group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• tamer abdelaziz, MD

  Faculty of medicine, Ain Shams University, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: March 15, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 29, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

EG (1)