Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Amount of 24 Hour Opioid Consumption
研究概览
简要总结
The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.
详细描述
This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Group allocation and instructions on preparing the injectate solution for the subcostal TAP block will be included in a sealed envelope. On the day of the surgery, the group allocation will be revealed to an anesthesiologist not involved with the research study. The anesthesiologist not involved in the study or the care of the patient will prepare the solution to be used for the subcostal TAP block.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-80 years old
- •Candidate for general anesthesia
- •Undergoing laparoscopic sleeve gastrectomy
- •Patients of participating surgeons
排除标准
- •Prior bariatric surgery of any kind
- •Previous abdominoplasty
- •Allergy or intolerance to one of the study medications
- •Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month)
- •History of alcohol/drug abuse
- •History of hepatic or renal insufficiency
- •Patient refusal
研究组 & 干预措施
Saline
Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
干预措施: Saline (Drug)
Bupivacaine
Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Amount of 24 Hour Opioid Consumption
时间窗: 24 Hours postoperative
Amount of intravenous (IV) opioid consumption within 24-hour period
次要结局
- Number of Participants Asked Area of Pain on the Body After Surgery(24 Hours postoperative)
- Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery(24 Hours postoperative)
- Amount of Intraoperative IV Opioid Consumption(average 2-3 Hours)
研究者
Christina Jeng
Associate Professor
Icahn School of Medicine at Mount Sinai