TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT

Summary

Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdomen remains a major source of postoperative pain. Adequate pain control is important as it has been shown to reduce medical complications, in-hospital death, shortens hospital stay, lessen chronic pain and disability, and in turn lower health-care costs. The current postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties, bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral nerve block. Although the TAP block has been found to be an effective pain-relief following major abdominal surgeries, its use has never been studied for breast reconstruction using abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a TAP block in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. This study has significant implications in improving both clinical care and health outcomes in patients undergoing this common method of breast reconstruction technique.

Conditions

• Transversus Abdominis Plane (TAP) Block Catheter
• DIEP or Free MS-TRAM Breast Reconstruction
• Local Pain Management
• Abdominal/ Donor Site

Interventions

DRUG

Bupivacaine (study group)

At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.

DRUG

Isotonic saline (control group)

At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.

Sponsors & Collaborators

• Canadian Society of Plastic Surgeons

  collaborator OTHER

• The Plastic Surgery Foundation

  collaborator OTHER

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Toni Zhong, MD, MHS · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• Canada

Study Locations