The Use of Transversus Abdominis Plane (TAP) Block in Autologous Breast Reconstruction Donor Site: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Mean Total Opioid Consumption
研究概览
简要总结
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.
详细描述
- Statement of Objectives/Specific Aims
The transversus abdominis plane (TAP) block is a newly developed block involving T6-L1 nerves that supply the anterior abdominal wall. Its effectiveness has been reported following major abdominal surgeries, but not following abdominally-based autologous tissue breast reconstruction. Thus, we propose a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TAP block in improving pain symptomatology following abdominally-based, autologous tissue breast reconstruction.
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.
The secondary outcomes of interest are to compare the following parameters:
A. Continuous outcomes i. Total in-hospital cumulative opioid consumption ii. Total in-hospital cumulative anti-nausea consumption iii. Quality of Recovery (QOR) score (0-18) iv. Duration of hospital stay
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Isotonic saline (control group) (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.
干预措施: Bupivacaine (study group) (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.
干预措施: Isotonic saline (control group) (Drug)
结局指标
主要结局
Mean Total Opioid Consumption
时间窗: first postoperative 48 hours
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.
次要结局
- First Bowel Movement(In-patient hospital stay, average 4-5 days)
- Pain Disability(Hospital discharge, average 4-5 days, 6 months and 1 year following discharge)
- Postoperative Nausea and Vomiting(In Hospital postoperative measures, average 4-5 days)
- Daily Pain Intensity Scores at Rest and With Movement(In Hospital postoperative measures, average 4-5 days)
- Time to Ambulation(In-patient hospital stay, average 4-5 days)
- Total In-hospital Cumulative Opioid Consumption(In-patient hospital stay average of 4 - 5 days)
- Quality of Recovery(In-patient hospital stay, first post operative 48 hours)
- Duration of Hospital Stay(In-patient hospital stay, average of 4-5 days)
- Anti-nausea Consumption(In-patient hospital stay, average 4-5 days)
- Sedation Level(In Hospital postoperative measures, average 4-5 days)
- Pain Frequency and Intensity(Hospital discharge, average 4-5 days, 6 months and 1 year following discharge)
- Anxiety and Depression(Hospital discharge, average 4-5 days, 6 months and 1 year following discharge)
- Health Related Quality of Life(Hospital discharge, average 4-5 days, 6 months and 1 year following discharge)