Effectiveness of Low-Dose Ketamine and Intravenous Lidocaine Vs. Fentanyl for Postoperative Pain for Patients Undergoing Elective Gynecologic Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting
• Interventions: Drug: Low dose intravenous ketamine

• Registration Number: NCT07213687
• Lead Sponsor: Dilla University

Brief 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 intraoperative pain in patients undergoing elective gynecologic surgery under general anesthesia at Dilla University General and Teaching Hospital and Hawassa University Specialized and Comprehensive Hospital from April 10, 2023, to June10, 2023.

Methodology: A multicentered, 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 receive low dose ketamine and IV lidocaine and control group (C) receiving fentanyl. The primary outcome variable is the postoperative pain score measured at PACU, 6hour, 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-10
• Primary Completion: 2024-05-10
• Study Completion: 2024-08-20
• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• ASA I and II patients between the ages of 18 and 65 undergoing elective gynecologic surgery under general anaesthesia

Exclusion Criteria

• Patients with allergies to any of the drugs used in the trial Patients with chronic pain Patients who are diagnosed with CNS diseases like psychiatric diseases, epilepsy Patients who are hypertensive and taking beta blockers, as well as those who have preoperative bradycardia, hypotension, or any type of heart block, Breastfeeding and pregnant women Patients weighing less than 40 kg or obese patients (BMI > 35 kg/m2) Patients with a history of smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
An Experimental or treatment group (T)	Low dose intravenous ketamine	The Experimental or treatment group (T) will receive ketamine 0.5 mg/kg bolus, then 0.2 mg/kg infusion, and IV lidocaine 1.5 kg/kg bolus. The same bolus dose of lidocaine will be repeated every 15 to 20 minutes.
Control group (C)	Low dose intravenous ketamine	The control group (C) will receive a conventional general anesthesia (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.

Primary Outcome Measures

Name	Time	Method
The numerical rating scale will measure the postoperative pain severity	From the patient's arrival at PACU to 24 hours postoperatively (at PACU, at 6 hours, 12 hours, and 24 hours).	Will be assessed by the validated numerical rating scale, a reliable tool for assessing pain intensity in all populations, regardless of literacy level which employs a 0-to-10 ratings. scale, with 0 representing no pain and 10 representing the worst possible pain. The English and Amharic versions of the scale are attached in

Secondary Outcome Measures

Name	Time	Method
The occurrence of postoperative nausea and vomiting (PONV)	At arrival at PACU to 24hours (at PACU, at 6 hours, 12 hours, and 24 hours)	The occurrence of postoperative nausea and vomiting, the nausea and vomiting score, and the use of medication for management will be recorded.

Trial Locations

Locations (1)

Dilla University; 🇪🇹 Awasa, Snnpr, Ethiopia