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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.
The study will take the form of a prospective randomised clinical trial. The following assessment tools will be used
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | 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. |
|
| Control | No Intervention | Patients will receive morphine up to 0.1mg/kg intraoperatively. Postoperative analgesia will be provided with oxycodone, paracetamol and diclofenac. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 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 |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denise M McCarthy, MB FCARCSI | Contact | 353 87 2341254 | dmc_btown@yahoo.co.uk | |
| Brian O'Donnell, MD FCARCSI | Contact | 353 21 4922135 | briodnl@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Denise M McCarthy, MB FCARCSI | Cork Universtiy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork Universtiy Hospital | Recruiting | Cork | Ireland |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| incidence of nausea and vomiting | 48 hours postoperatively |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000588 |
| Amines |