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Effectiveness of Low-Dose Ketamine and Intravenous Lidocaine Versus Fentanyl for Postoperative Pain

NCT07213687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-10-14

No results posted yet for this study

Summary

Background: Rational approaches to perioperative patient management have been used to meet intraoperative analgesic needs and avoid opioid-related adverse effects. A combination of drugs, such as ketamine, sodium channel blockers, anti-inflammatories, and alpha-2 agonists, can be used. This study aimed to compare the effectiveness of low-dose ketamine and intravenous lidocaine with fentanyl for intraoperative pain in patients undergoing gynecologic surgery.

Objective: To determine the effectiveness of low-dose ketamine and intravenous lidocaine versus fentanyl for postoperative pain in patients undergoing elective gynecologic surgery under general anesthesia at Dilla University General and Teaching Hospital from April 10, 2023, to June 10, 2023.

Methodology: A randomized, controlled, single-blind trial will be conducted with 68 adult patients undergoing elective gynecologic surgery under GA. Eligible patients undergoing gynecologic surgery in both study areas will be allocated by a computer-generated random allocation sequence in equal ratios to the treatment group (T) receiving low-dose ketamine and IV lidocaine and the control group (C) receiving fentanyl. The primary outcome variable is the postoperative pain score measured at PACU, 6 hours, 12 hours, and 24 hours postoperatively. Secondary outcomes are analgesic consumption, postoperative hypoxemia, Quality of immediate postoperative recovery assessed by the quality of recovery (QoR-40) questionnaire on postoperative days 1, and postoperative nausea and vomiting. It will be collected up to 24 hours postoperatively. Data will be analyzed using Student's t-test, analysis of variance, chi-square test, and Mann-Whitney test. Parametric and non-parametric categorical data will be analyzed using the chi-squared test and Fisher's exact test, respectively. Statistical significance will be a p-value of 0.05.

Work plan and budgeting: - study will be conducted from April 10, 2023, to June 10, 2023, with a cost of 41625 ETB.

Conditions

  • Postoperative Pain
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Low dose intravenous ketamine

Patients in the treatment group will be administered through a Ketamine IV bolus of 0.5 mg/kg during the induction phase with propofol of 3 mg/kg, followed by a continuous infusion of ketamine of 0.2 mg/kg/hr. Before induction, a lidocaine bolus of 1.5 mg/kg will be given, and the same dose of lidocaine will be administered every 15 to 20 minutes after induction of anesthesia until the start of skin closure. Patients in control group will receive a conventional GA with fentanyl 2µg/kg given during induction of anesthesia and one fourth of initial dose of fentanyl will be given over 20-30 minutes.

Sponsors & Collaborators

  • Dilla University

    lead OTHER

Principal Investigators

  • Amanuel A Asefa, Msc. Degree · Arbaminch College of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2024-05-10
Completion
2024-08-20
FDA Drug
Yes

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07213687 on ClinicalTrials.gov