Wound Infiltration and Breast Cancer Surgery

Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: infiltration with ropivacaine solution

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ropivacaine; treated group (ropivacaine infiltration)	Procedure: infiltration with ropivacaine solution; Patients are allocated randomly into two arms on the morning of surgery, using random numbers and sealed envelopes. 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 and nitrous oxide for maintenance. Dexamethasone 4 mg was given intravenously after anaesthetic induction for prevention of postoperative nausea and vomiting. Twenty milliliters of the allocated solution were 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.; Other Names: naropeine
Placebo Comparator: placebo; placebo group : infiltration with saline solution	Procedure: infiltration with ropivacaine solution; Patients are allocated randomly into two arms on the morning of surgery, using random numbers and sealed envelopes. 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 and nitrous oxide for maintenance. Dexamethasone 4 mg was given intravenously after anaesthetic induction for prevention of postoperative nausea and vomiting. Twenty milliliters of the allocated solution were 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.; Other Names: naropeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30% decrease in VAS score on mobilization on the day of 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.	patients will be followed during all the duration of hospital stay and 2 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease in pain score at rest	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.	duration of hospitalisation and 2 month after surgery
decrease in analgesic rescue consumption	patients received non opioid analgesic (paracetamol) on demand postoperatively	during hospital stay
improvement in quality of life scoring	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.	during hospital stay

Collaborators and Investigators

• Sponsor: Tenon Hospital, Paris
• Investigators: Principal Investigator: Francis Bonnet, MD, Tenon Hospital

Publications and helpful links

General Publications

• Vigneau A, Salengro A, Berger J, Rouzier R, Barranger E, Marret E, Bonnet F. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection. BMC Anesthesiol. 2011 Nov 24;11:23. doi: 10.1186/1471-2253-11-23.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2011
• Last Update Submitted That Met QC Criteria: July 27, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: breast surgery : postoperative pain; ropivacaine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: TenonH; bordereau 52 rang 5 N°338 (Other Identifier: Direction Regionale des affaires sanitaires et sociales)