Pain Management Following TRAM Flap for Breast Reconstruction

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this pilot study is to examine the efficacy of the ON~Q Pain Relief System plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery. The primary outcome measure will be postoperative opioid analgesia requirements. Other outcomes will also be assessed, including pain scores, quality of recovery, and resource utilization.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: I-Flow
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Patients with or undergoing unilateral elective free TRAM flap for breast reconstruction, immediate or delayed, with or without a surgical revision of the contralateral breast for asymmetry.

• American Society of Anesthesiology Physical Status I - III patients.

• Patients has given voluntary written informed consent before performance of any study-related procedure.

Exclusion Criteria:

• Patients undergoing bilateral TRAM flap reconstruction.

• Patients with a prior allergic reaction to Marcaine (bupivacaine) or other amide local anesthetics.

• Patients with a prior allergic reaction to Morphine and Hydromorphone.

• Patients undergoing any other unrelated surgical procedure to the breast reconstruction.

• Patient refusal to participate.

• Patient required major abdominal surgery within four weeks prior to enrollment.

• Patients being treated for chronic pain or using daily intake of opioid analgesics.

• Patients with a history of abuse of recreational drugs or alcohol.

• Patients with any laboratory values or underlying disease, which in the investigator's opinion would preclude them from participation in the trial, specifically: (A) significant liver dysfunction (eg. bilirubin, AST and/or ALT >1.5 times the upper limit of normal value (B) cardiac conduction defects noted by history or on the pre-op screening EKG.

• Pregnant or breast feeding.