Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery

NCT01314144 | Unknown Phase 3

• 1 other identifier: AC-CUH
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Axillary clearance forms part of the surgical armamentarium for the treatment of breast cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed for the decreased use of axillary clearance, it remains a frequently performed operation. Axillary clearance is associated with moderate postoperative pain. We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing axillary lymph node clearance surgery.

Conditions

Breast Cancer

Keywords

axillary clearance; wound infiltration; wound infusion; local anaesthetic wound infusion

Outcome Measures

Primary Outcomes (1)

• Pain on abducting the arm on the operative side to 90 degrees as measured using a 100mm visual analogue scale at 6 hours following surgery.

  6 hours postoperatively

Secondary Outcomes (3)

• Pain (at rest and on movement) in the recovery room and at 6, 24 and 48 hours after surgery.

  48 hours postoperatively

• Cumulative Oxycodone consumption at 6, 24 and 48 hours after surgery

  48 hours postoperatively

• incidence of nausea and vomiting

  48 hours postoperatively

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Patients will receive intraoperative wound soakage with 20ml of 0.5% bupivacaine with adrenaline by the surgeon before closure and receive a continuous infusion of 4ml/hr of 0.2% bupivacaine delivered by an elastomeric pump the catheter of which will be placed by the surgeon in the wound before closure. Postoperative anlagesia will be provided with oxycodone, paracetamol and diclofenac.

Drug: Bupivacaine

Control

NO INTERVENTION

Patients will receive morphine up to 0.1mg/kg intraoperatively. Postoperative analgesia will be provided with oxycodone, paracetamol and diclofenac.

Interventions

Bupivacaine DRUG

intraoperative wound soakage with 20ml of 0.5% bupivacaine with epinephrine and continuous infusion of 4ml/hr of 0.2% bupivacaine for 48 hours postoperatively

Bupivacaine

Eligibility Criteria

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

You may qualify if:

• Patients undergoing axillary clearance surgery
• ASA physical status I - III

You may not qualify if:

• Patient refusal
• Pre-existing pain conditions
• Regular use of opioid analgesia
• Pregnancy
• Severe cardiac, renal or hepatic disease
• Psychiatric illness precluding ability to give informed consent
• Intercurrent neurological disease
• Contraindications to bupivacaine or morphine use

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork Universtiy Hospital

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bupivacaine

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

• Denise M McCarthy, MB FCARCSI

  Cork Universtiy Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise M McCarthy, MB FCARCSI

CONTACT

353 87 2341254; dmc_btown@yahoo.co.uk

Brian O'Donnell, MD FCARCSI

CONTACT

353 21 4922135; briodnl@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 14, 2011

Record last verified: 2011-03

Locations

IE (1)