Abdominal/ Donor Site Clinical Trial
Official title:
The Use of Transversus Abdominis Plane (TAP) Block in Autologous Breast Reconstruction Donor Site: A Randomized, Double-blind, Placebo-controlled Trial
| Verified date | March 2015 |
| Source | University Health Network, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto General Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto | Canadian Society of Plastic Surgeons, Plastic Surgery Educational Foundation |
Canada,
Zhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SO. Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast recon — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Total Opioid Consumption | The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter. | first postoperative 48 hours | No |
| Secondary | Total In-hospital Cumulative Opioid Consumption | Total in-hospital cumulative opioid consumption levels | In-patient hospital stay average of 4 - 5 days | No |
| Secondary | Daily Pain Intensity Scores at Rest and With Movement | Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10) | In Hospital postoperative measures, average 4-5 days | No |
| Secondary | Pain Disability | Pain Disability Index Scores | Hospital discharge, average 4-5 days, 6 months and 1 year following discharge | No |
| Secondary | First Bowel Movement | Time to first bowel movement (# of days) | In-patient hospital stay, average 4-5 days | No |
| Secondary | Anti-nausea Consumption | Total in-hospital cumulative anti-nausea consumption | In-patient hospital stay, average 4-5 days | No |
| Secondary | Quality of Recovery | Quality of Recovery (QOR) score (0-18) | In-patient hospital stay, first post operative 48 hours | No |
| Secondary | Duration of Hospital Stay | Duration of hospital stay (# of days) | In-patient hospital stay, average of 4-5 days | No |
| Secondary | Postoperative Nausea and Vomiting | Postoperative nausea and vomiting (score of 0-3) | In Hospital postoperative measures, average 4-5 days | No |
| Secondary | Sedation Level | Sedation score in-patient | In Hospital postoperative measures, average 4-5 days | No |
| Secondary | Pain Frequency and Intensity | Short-form McGill Pain Questionnaire Score | Hospital discharge, average 4-5 days, 6 months and 1 year following discharge | No |
| Secondary | Anxiety and Depression | Hospital Anxiety and Depression Scale Score | Hospital discharge, average 4-5 days, 6 months and 1 year following discharge | No |
| Secondary | Health Related Quality of Life | Short-form health-related quality of life 36 Scores | Hospital discharge, average 4-5 days, 6 months and 1 year following discharge | No |
| Secondary | Time to Ambulation | Time to ambulation (# of days) | In-patient hospital stay, average 4-5 days | No |