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Postoperative PainPhase 4Vs(versus)NCT07213687

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

A Phase 4 study testing Low dose intravenous ketamine in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Dilla University at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
What is being tested?
Low dose intravenous ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEthiopia
Study dates
10 Jun 2023to 20 Aug 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site
  • Dilla University

    Awasa, Snnpr, 13

Other trials in Ethiopia

About this study

Official title: Effectiveness of Low-Dose Ketamine and Intravenous Lidocaine Versus Fentanyl for Postoperative Pain for Patients Undergoing Elective Gynecologic Surgery Under General Anesthesia: A Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

After obtaining ethical clearance from Dilla University College of Health Sciences and Medicine's ethics review board, a structured questionnaire will be developed and translated into the respective languages by the principal investigator (PI). Two BSC anesthetists involved in patient management will be selected at the study area and trained in the overall process of participant handling and data collection.

During the preoperative period Patients undergoing gynecologic operations during the study period will be assessed and informed about the study process and anesthesia on the day before surgery. The patient will receive maintenance fluid, have bilateral peripheral IV lines secured, and will be NPO the night before surgery. On the morning of the procedure, both a standard informed consent form for the procedure and a separate consent form for the study were available.

The availability and functionality of the bilateral IV line and NPO status will be checked, and prophylactic drugs will be given. Standard preoperative questionnaires were used, and data were collected through patient responses and medical records, such as patient monitoring and charts.

During the intraoperative period Routine ASA monitoring will be checked and applied for patients in both groups when they present to the OR. The functionality and availability of the bilateral IV line and urinary catheter were rechecked. Propofol (3 mg/kg) was used to induce anesthesia after the patient had been pre-oxygenated for both groups. An intravenous bolus of 0.5 mg/kg of ketamine during the induction phase for patients in the treatment group, then a continuous infusion of 0.2 mg/kg/hr. 0f ketamine. A bolus of 1.5 mg/kg was given before induction, and the same dose of lidocaine was administered every 15 to 20 minutes after induction of anesthesia until the start of skin closure.

Patients in the control group were induced with fentanyl 2 μg/kg given during induction of anesthesia with propofol 3mg/kg. 0.5 μg /kg of fentanyl was given every 20-30 minutes up to the start of skin closure.

Intubation was performed after giving 1.5-2 mg/kg IV suxamethonium. Inhalational anesthetics as availabilities (Isoflurane 0.75-2% and Halothane 1%_ 2%) were opened after the position of the ETT was confirmed, and Dexamethasone 0.15mg/kg IV bolus was given after securing the ETT.

Anesthesia was maintained with inhalational agents according to the patient's tidal volume of 6-8 ml/kg adjusted to maintain oxygen saturation >95% with 3- 4 ml 100% oxygen flow, and end-tidal CO2 between 32 and 45 mmHg. Muscle relaxation was maintained with vecuronium 0.8 mg/kg. Intraoperative anesthesia depth was assessed by clinical signs as well as by patient monitoring. Estimated intraoperative blood loss was supplied with ringer lactate or normal saline.

The intraoperative participants' data were collected from the anesthesia record chart and patient monitoring. Intraoperative hemodynamic variables were collected every 10 minutes. Intraoperative cardiac adverse events such as intraoperative bradycardia (pulse rate less than 50 bpm), tachycardia (PR greater than 100 bpm), hypertension, and hypotension we diagnosed and managed as per institutional protocol. Intraoperative nausea or vomiting in both groups was also managed as an institutional protocol.

When the surgeon began skin closure, the inhalational agent turned off. A pre-prepared reversal agent bolus (neostigmine 0.05 mg/kg with atropine 0.02 mg/kg IV) was administered for patients given long-acting muscle relaxants after checking the adequacy of spontaneous ventilation, adequate movement of the respiratory bag, oxygen saturation >95percentage and ETCO2 between 32 and 45 mmHg after the skin is closed.

During the postoperative period The postoperative pain severity was assessed by the validated VAS starting from the patient's discharge from PACU to 24 hours postoperatively. Data was collected at discharge from PACU, at 6 hours, 12 hours, and 24 hours postoperatively. PONV data were collected from the time of arrival at PACU at 6 hours, 12 hours, and 24 hours postoperatively according to the patient's signs and symptoms.

Being tested
Low dose intravenous ketamine
Medical subject headings
Pain, Postoperative, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose intravenous ketamineDrug

    Also called Intravenous lidocaine, Intravenous fentanyl

    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.

Study groups in NCT07213687
Study groupRoleWhat they receive
An Experimental or treatment group (T)ExperimentalThe 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.
Receives: Drug: Low dose intravenous ketamine
Control group (C)Active comparatorThe 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.
Receives: Drug: Low dose intravenous ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (1)
  1. The occurrence of postoperative nausea and vomiting (PONV)

    The occurrence of postoperative nausea and vomiting, the nausea and vomiting score, and the use of medication for management will be recorded.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start10 Jun 2023
  3. Primary completion10 May 2024
  4. Study completion20 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213687
Sponsor's protocol ID
duirb/037/23-05
Acronym
Vs(versus)
Status last verified
Oct 2025
First submitted
2 Oct 2025
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: will share after the final result.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low dose intravenous ketamine in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Dilla University at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The numerical rating scale will measure the postoperative pain severity (time frame: From the patient's arrival at PACU to 24 hours postoperatively (at PACU, at 6 hours, 12 hours, and 24 hours).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

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