Wound Infiltration and Breast Cancer Surgery

NCT01404377 | Completed Phase 4

• 2 other identifiers: TenonHbordereau 52 rang 5 N°338
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

breast surgery : postoperative pain; ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• decrease in pain score at rest

  duration of hospitalisation and 2 month after surgery

• decrease in analgesic rescue consumption

  during hospital stay

• improvement in quality of life scoring

  during hospital stay

Study Arms (2)

ropivacaine

ACTIVE COMPARATOR

treated group (ropivacaine infiltration)

Procedure: infiltration with ropivacaine solution

placebo

PLACEBO COMPARATOR

placebo group : infiltration with saline solution

Procedure: infiltration with ropivacaine solution

Interventions

infiltration with ropivacaine solution PROCEDURE

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.

Also known as: naropeine

placebo; ropivacaine

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tenon Hospital, Paris: lead

Study Sites (1)

Hopital Tenon

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 22114900 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Francis Bonnet, MD

  Tenon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: July 28, 2011
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 28, 2011

Record last verified: 2011-05

Locations

FR (1)