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Phase 4 N=93 Randomized Quadruple-blind Treatment

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

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

Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Mean Total Opioid Consumption — 30.0; 20.7 mg — p=0.02

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Bupivacaine (study group) (Drug); Isotonic saline (control group) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University Health Network, Toronto
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Total Opioid Consumption
30.0; 20.7 0.02 sig
SECONDARY
Total In-hospital Cumulative Opioid Consumption
SECONDARY
Daily Pain Intensity Scores at Rest and With Movement
SECONDARY
Pain Disability
SECONDARY
First Bowel Movement
SECONDARY
Anti-nausea Consumption
SECONDARY
Quality of Recovery
SECONDARY
Duration of Hospital Stay
SECONDARY
Postoperative Nausea and Vomiting
SECONDARY
Sedation Level
SECONDARY
Pain Frequency and Intensity
SECONDARY
Anxiety and Depression
SECONDARY
Health Related Quality of Life
SECONDARY
Time to Ambulation

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.

Eligibility Criteria

Inclusion Criteria

-Pre-operative eligibility:

  • Patients above the age of 18, no upper age limit
  • English-speaking
  • Delayed reconstruction (mastectomy already performed) or immediate reconstruction (mastectomy at the same time as reconstruction)
  • Reconstruction using abdominal tissues including free MS-TRAM or DIEP

Exclusion Criteria

  • Patient refusal
  • Inability to give informed consent
  • BMI > 40
  • Allergy to Bupivacaine
  • Known cardiac or liver disease (contraindicated for Bupivacaine use)
  • Patients who will undergo any of the following:
  • Implant breast reconstruction
  • Combined implant and autologous tissue reconstruction
  • Non-abdominally based autologous tissue reconstruction
  • Nonmicrosurgical abdominally based breast reconstruction (pedicled TRAM flap)
  • Drug addiction
  • Opioid tolerance defined as preoperative opioid use of >50 mg PO morphine equivalent
  • Psychiatric illness
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01398982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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