Phase 4
N=93
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
Bottom Line
View on ClinicalTrials.gov: NCT01398982 ↗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
| Outcome | Result | p-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
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.