Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery
NCT ID: NCT01314144
Last Updated: 2011-03-14
Study Results
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Basic Information
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UNKNOWN
PHASE3
42 participants
INTERVENTIONAL
2010-08-31
2011-10-31
Brief Summary
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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.
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Detailed Description
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* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Control
Patients will receive morphine up to 0.1mg/kg intraoperatively. Postoperative analgesia will be provided with oxycodone, paracetamol and diclofenac.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* ASA physical status I - III
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cork University Hospital
OTHER
Responsible Party
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Cork University Hospital
Principal Investigators
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Denise M McCarthy, MB FCARCSI
Role: PRINCIPAL_INVESTIGATOR
Cork Universtiy Hospital
Locations
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Cork Universtiy Hospital
Cork, , Ireland
Countries
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Central Contacts
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Other Identifiers
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AC-CUH
Identifier Type: -
Identifier Source: org_study_id
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