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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6 hours postoperatively

Safety Issue:

No

Principal Investigator

Denise M McCarthy, MB FCARCSI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cork Universtiy Hospital

Authority:

Ireland: Research Ethics Committee

Study ID:

AC-CUH

NCT ID:

NCT01314144

Start Date:

August 2010

Completion Date:

October 2011

Related Keywords:

  • Breast Cancer
  • axillary clearance
  • wound infiltration
  • wound infusion
  • local anaesthetic wound infusion
  • Breast Neoplasms

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