Wound Infiltration and Breast Cancer Surgery

This study has been completed.
Sponsor:
Information provided by:
Tenon Hospital, Paris
ClinicalTrials.gov Identifier:
NCT01404377
First received: April 11, 2011
Last updated: July 27, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Breast Cancer
Procedure: infiltration with ropivacaine solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery

Resource links provided by NLM:


Further study details as provided by Tenon Hospital, Paris:

Primary Outcome Measures:
  • 30% decrease in VAS score on mobilization on the day of surgery [ Time Frame: patients will be followed during all the duration of hospital stay and 2 months after surgery ] [ Designated as safety issue: No ]
    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:
  • decrease in pain score at rest [ Time Frame: duration of hospitalisation and 2 month after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
    patients received non opioid analgesic (paracetamol) on demand postoperatively

  • improvement in quality of life scoring [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: naropeine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404377

Locations
France
Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Tenon Hospital, Paris
Investigators
Principal Investigator: Francis Bonnet, MD Tenon Hospital
  More Information

No publications provided

Responsible Party: F Bonnet, association pour la recherche en anesthésie réanimation hôpital Tenon
ClinicalTrials.gov Identifier: NCT01404377     History of Changes
Other Study ID Numbers: TenonH, bordereau 52 rang 5 N°338
Study First Received: April 11, 2011
Last Updated: July 27, 2011
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Tenon Hospital, Paris:
breast surgery : postoperative pain; ropivacaine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pharmaceutical Solutions
Ropivacaine
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014