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

NCT07213687 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: duirb/037/23-05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• The numerical rating scale will measure the postoperative pain severity

  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

  From the patient's arrival at PACU to 24 hours postoperatively (at PACU, at 6 hours, 12 hours, and 24 hours).

Secondary Outcomes (1)

• The occurrence of postoperative nausea and vomiting (PONV)

  At arrival at PACU to 24hours (at PACU, at 6 hours, 12 hours, and 24 hours)

Study Arms (2)

An Experimental or treatment group (T)

EXPERIMENTAL

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.

Drug: Low dose intravenous ketamine

Control group (C)

ACTIVE COMPARATOR

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.

Drug: Low dose intravenous ketamine

Interventions

Low dose intravenous ketamine DRUG

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.

Also known as: Intravenous lidocaine, Intravenous fentanyl

An Experimental or treatment group (T); Control group (C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Adult patients between the ages of 18 and 65 will undergo elective gynecologic surgery under general anesthesia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dilla University: lead

Study Sites (1)

Dilla University

Awasa, Snnpr, 13, Ethiopia

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Amanuel A Asefa, Msc. Degree

  Arbaminch College of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants will not be allowed to now the group they allocated. The anesthetist involved in patient management will prepare drugs. Apart from patient management, the anaesthetist will not be involved in any other study processes. Participants will be given the study group code and allowed to present it to OR. Participants assigned to groups will not know which group they have been selected for.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effectiveness of Low-Dose Ketamine and Intravenous Lidocaine Versus Fentanyl for Postoperative Pain for Patients Undergoing Elective Gynecologic Surgery

Model Details: The eligible participants presenting for gynecologic surgery in both study areas will be allocated to study groups by a computer-generated random allocation sequence created by an independent anesthetist using Microsoft Excel 2016 with a 1:1 allocation to the treatment group (T) and control group (C). The treatment group 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. The 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.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: June 10, 2023
• Primary Completion: May 10, 2024
• Study Completion: August 20, 2024
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)