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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314144
Recruitment Status : Unknown
Verified March 2011 by Cork University Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2011
Last Update Posted : March 14, 2011
Information provided by:
Cork University Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Bupivacaine Phase 3

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  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Continuous Wound Infusion of 0.2% Bupivacaine Provide Superior Analgesia Compared to Standard Opioid-based Therapy in Patients Following Axillary Clearance Surgery?
Study Start Date : August 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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. [ Time Frame: 6 hours postoperatively ]

Secondary Outcome Measures :
  1. Pain (at rest and on movement) in the recovery room and at 6, 24 and 48 hours after surgery. [ Time Frame: 48 hours postoperatively ]
  2. Cumulative Oxycodone consumption at 6, 24 and 48 hours after surgery [ Time Frame: 48 hours postoperatively ]
  3. incidence of nausea and vomiting [ Time Frame: 48 hours postoperatively ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314144

Contact: Denise M McCarthy, MB FCARCSI 353 87 2341254
Contact: Brian O'Donnell, MD FCARCSI 353 21 4922135

Cork Universtiy Hospital Recruiting
Cork, Ireland
Principal Investigator: Denise M McCarthy, MB FCARCSI         
Sponsors and Collaborators
Cork University Hospital
Principal Investigator: Denise M McCarthy, MB FCARCSI Cork Universtiy Hospital

Responsible Party: Denise McCarthy, Cork University Hospital Identifier: NCT01314144     History of Changes
Other Study ID Numbers: AC-CUH
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 2011

Keywords provided by Cork University Hospital:
axillary clearance
wound infiltration
wound infusion
local anaesthetic wound infusion

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents