Breast Cancer Clinical Trial
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?
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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | October 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ireland | Cork Universtiy Hospital | Cork |
Lead Sponsor | Collaborator |
---|---|
Cork University Hospital |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Pain (at rest and on movement) in the recovery room and at 6, 24 and 48 hours after surgery. | 48 hours postoperatively | No | |
Secondary | Cumulative Oxycodone consumption at 6, 24 and 48 hours after surgery | 48 hours postoperatively | No | |
Secondary | incidence of nausea and vomiting | 48 hours postoperatively | No |
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