Administration of Ketamine to Prevent the Post-operative Pain

NCT00210210 | Completed Phase 3 Results

• 2 other identifiers: IB2004-04KETAMINE
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Postoperative Pain; Breast Cancer

Keywords

Post-operative-pain; Breast cancer; Morphine; Analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption (First 48 Post-operative Hours)

  Number of participants with at least one consumption of morphine within 48 hours following surgery.

  within 48 hours following surgery

Secondary Outcomes (1)

• Post-operative Pain

  48 hours after surgery

Study Arms (2)

Ketamine Arm

EXPERIMENTAL

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

Reference Arm

SHAM COMPARATOR

Induction and anesthetic maintenance without ketamine (reference arm / saline solution)

Drug: Saline solution

Interventions

Ketamine DRUG

Ketamine Arm

Saline solution DRUG

Reference Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms; Agnosia

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials' Unit
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• Sylvie COLOMBANI, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 31, 2004
• Primary Completion: July 31, 2005
• Study Completion: December 31, 2005
• Last Updated: September 19, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)