Administration of Ketamine to Prevent the Post-operative Pain (KETAMINE)

September 8, 2025 updated by: Institut Bergonié

Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology

The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients 18 years older
  • ASA class 1 or 2
  • with surgery of breast cancer (mastectomy or tumorectomy)

Exclusion criteria:

.Kétamine hypersensitivity

  • Major psychiatric disorders
  • Major cardio-vascular disorders
  • Major neurologic disorders
  • Major ocular disorders
  • Morphine in pre-operative period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine Arm

Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol".

Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol".
Drug: Ketamine
Sham Comparator: Reference Arm
Induction and anesthetic maintenance without ketamine (reference arm / saline solution)
Drug: Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Consumption (First 48 Post-operative Hours)
Time Frame: within 48 hours following surgery
Number of participants with at least one consumption of morphine within 48 hours following surgery.
within 48 hours following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain
Time Frame: 48 hours after surgery

Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain).

A VAS score >= 4 wwas considered as "Pain". A VAS sore <4 was considered as "No pain".
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: Sylvie COLOMBANI, MD, Institut Bergonié

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2004

Primary Completion (Actual)

July 31, 2005

Study Completion (Actual)

December 31, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 21, 2005

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2004-04
  • KETAMINE (Other Identifier: Institut Bergonié)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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