Is the Analgesic Effect of the Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery Useful?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Opioid consumption over the first 24 hours following LGBS.
研究概览
简要总结
Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid obesity, which is performed under general anesthesia. TAP block is an analgesic strategy covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are located. As far as the investigators know, this analgesic technique has never been studied in LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass surgery, compared to conventional therapy only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III
- •18-70 years of age, inclusive
- •scheduled for elective laparoscopic gastric-bypass surgery.
排除标准
- •contraindications to regional blockade (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- •pregnancy
- •history of alcohol or drug dependence/abuse
- •history of long term opioid intake or chronic pain disorder
- •history of significant psychiatric conditions that may affect patient assessment
- •inability to understand the informed consent and demands of the study
研究组 & 干预措施
Conventional management
On the ward, patients will be prescribed acetaminophen 1 g every 6 hours. If additional analgesia is required, patients will take oxycodone 5-10 mg up to every 2 hours or iv morphine. Patients with contraindications to oxycodone will be prescribed oral hydromorphone 1-2 mg instead. This is the current standard of care at Toronto Western Hospital.
干预措施: Conventional Managment (Other)
TAP Block+Conventional Management
The TAP block will be performed after the induction, before the surgery, by an anesthesiologist with experience of at least 10 successful TAP blocks.Also patients will be prescribed acetaminophen 1 g every 6 hours. If additional analgesia is required, patients will take oxycodone 5-10 mg(oral hydromorphone 1-2 mg) up to every 2 hours or iv morphine.
干预措施: TAP-Block (Procedure)
结局指标
主要结局
Opioid consumption over the first 24 hours following LGBS.
时间窗: 24 hrs
Opioid consumption will be expressed in terms of milligrams doses of PO morphine. If other opioids are used, doses will be converted to the equivalent PO morphine dose using standard opioid dosage conversion tables.
次要结局
- Duration of block(48 hours)
- Pain scores(48 hours)
- Block procedure time(30 minutes)
- Opioid consumption at 48 hours(48 Hours)
- incidence of itching, and number of antipruritic medication administrations(48 hours)
- TAP block complications(48 hours)
- incidence of nausea and vomiting, and number of antiemetic medication administrations(during hospital stay average of 2 - 3 days)