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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Cork University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01314144
First received: March 11, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Bupivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Cork University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain (at rest and on movement) in the recovery room and at 6, 24 and 48 hours after surgery. [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
  • Cumulative Oxycodone consumption at 6, 24 and 48 hours after surgery [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
  Eligibility

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

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
  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: NCT01314144

Contacts
Contact: Denise M McCarthy, MB FCARCSI 353 87 2341254 dmc_btown@yahoo.co.uk
Contact: Brian O'Donnell, MD FCARCSI 353 21 4922135 briodnl@gmail.com

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

No publications provided

Responsible Party: Denise McCarthy, Cork University Hospital
ClinicalTrials.gov Identifier: NCT01314144     History of Changes
Other Study ID Numbers: AC-CUH
Study First Received: March 11, 2011
Last Updated: March 11, 2011
Health Authority: Ireland: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 21, 2014