Administration of Ketamine to Prevent the Post-operative Pain

Phase 3

Completed

• Conditions: Postoperative Pain; Breast Cancer
• Interventions: Drug: Ketamine; Drug: Saline solution

• Registration Number: NCT00210210
• Lead Sponsor: Institut Bergonié

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-31
• Primary Completion: 2005-07-31
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2005-12-31
• Results First Submitted: 2025-08-19
• Results First Submitted QC: 2025-08-19
• Status Verified: 2025-09
• Results First Posted: 2025-09-08
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Arm	Ketamine	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".
Reference Arm	Saline solution	Induction and anesthetic maintenance without ketamine (reference arm / saline solution)

Primary Outcome Measures

Name	Time	Method
Morphine Consumption (First 48 Post-operative Hours)	within 48 hours following surgery	Number of participants with at least one consumption of morphine within 48 hours following surgery.

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain	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".

Trial Locations

Locations (1)

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest; 🇫🇷 Bordeaux, France