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

Does Continuous Wound Infusion of 0.2% Bupivacaine Provide Superior Analgesia Compared to Standard Opioid-based Therapy in Patients Following Axillary Clearance Surgery?

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Bupivacaine

Detailed Description

The study will take the form of a prospective randomised clinical trial. The following assessment tools will be used

• The visual analogue scale (VAS) consists of a 100 mm horizontal line with the two end points labelled "no pain" and "worst pain ever". Patients are asked to mark on the line a point that corresponds to the level of pain intensity they feel. The score is obtained by measuring the distance (mm) from the left end of the line.
• The short-form McGill Pain Questionnaire (SF-MPQ) consists of 15 representative words from the sensory and affective categories of the standard McGill Pain Questionnaire. It also includes the present pain intensity and a VAS to provide overall indices of pain intensity. It has been shown to be sensitive to clinical changes brought about by various interventions, postoperative analgesic drugs (6).
• The Pain Catastrophising Score (PCS) is a 13 item instrument which asks patient to reflect on past painful experiences, and to indicate the degree to which they experienced each of these 13 thoughts or feelings, on 5-point scales with the end points; 0 = not at all, 4 = all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness (7).
• The Hospital Anxiety and Depression Score (HADS) is a 14-item scale, which screens for these, the two most common disturbances encountered in a medical setting (8).

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Denise M McCarthy, MB FCARCSI; Phone Number: 353 87 2341254; Email: dmc_btown@yahoo.co.uk
• Study Contact Backup: Name: Brian O'Donnell, MD FCARCSI; Phone Number: 353 21 4922135; Email: briodnl@gmail.com

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • Cork Universtiy Hospital
    • Principal Investigator: Denise M McCarthy, MB FCARCSI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine; 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; 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
No Intervention: Control; Patients will receive morphine up to 0.1mg/kg intraoperatively. Postoperative analgesia will be provided with oxycodone, paracetamol and diclofenac.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cork University Hospital
• Investigators: Principal Investigator: Denise M McCarthy, MB FCARCSI, Cork Universtiy Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): March 14, 2011
• Last Update Submitted That Met QC Criteria: March 11, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: wound infiltration; wound infusion; axillary clearance; local anaesthetic wound infusion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: AC-CUH