Wound Infiltration and Breast Cancer Surgery

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: infiltration with ropivacaine solution

• Registration Number: NCT01404377
• Lead Sponsor: Tenon Hospital, Paris

Brief Summary

Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection

Detailed Description

This is a prospective, double-blind, randomized, single centre study Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection are included in the study. Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality are excluded.

Patients are allocated randomly into two groups on the morning of surgery, using random numbers and sealed envelopes. general anaesthesia using propofol and sufentanil for induction, and sevoflurane In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under general anesthesia with propofol, sufentanil, sevoflurane and nitrous oxide for maintenance. Twenty milliliters of the allocated solution are used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision. Postoperatively, 8 tablets of paracetamol 500 mg were let at patient' disposal every 24 hours for 3 days. If pain control is not adequate patients receive 5 mg of subcutaneous morphine as a rescue.

Pain intensity is measured on a visual analogue scale graded from 0 to 100. Measurements are performed at rest and on operated arm abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery. The value of maximum abduction angle is noted.

To evaluate quality of life patients are asked to score on a 4 points scale graded from 0 (the worst) to 3 (the best) the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. A global score is attributed to each patient as the sum of categorical scores. Evaluation is performed at 24, 48 and 72 hour after the end of surgery.

Patients are evaluated at two month for residual pain at rest and on movement using a visual analogue scale and for quality of life as previously defined.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2011-04-11
• Status Verified: 2011-05
• Study First Submitted QC: 2011-07-27
• Last Update Submitted: 2011-07-27
• Study First Posted: 2011-07-28
• Last Update Posted: 2011-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection

Exclusion Criteria

• Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	infiltration with ropivacaine solution	treated group (ropivacaine infiltration)
placebo	infiltration with ropivacaine solution	placebo group : infiltration with saline solution

Primary Outcome Measures

Name	Time	Method
30% decrease in VAS score on mobilization on the day of surgery	patients will be followed during all the duration of hospital stay and 2 months after surgery	Pain intensity was measured on a VAS graded from 0 to 100, on operated arm at maximum abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery.

Secondary Outcome Measures

Name	Time	Method
decrease in pain score at rest	duration of hospitalisation and 2 month after surgery	Pain intensity was measured on a VAS graded from 0 to 100, at rest at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery.
decrease in analgesic rescue consumption	during hospital stay	patients received non opioid analgesic (paracetamol) on demand postoperatively
improvement in quality of life scoring	during hospital stay	Quality of life was scored on a 4 points scale graded from 0 (the worst) to 3 (the best) for the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. Evaluation was performed at 24, 48 and 72 hour after the end of surgery.

Trial Locations

Locations (1)

Hopital Tenon; 🇫🇷 Paris, France