Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- pain scores at 24 hours in LA-TAP and NO TAP block groups
研究概览
简要总结
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group.
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 & 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 & 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
详细描述
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 & 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 & 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Patients will be randomized in two arms , LA-TAP , NO-TAP block . Each patient would fill out the pain score sheet and number of narcotic medications she used in first 24h, 48h and 72 h post operatively .
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
- Single (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
- 是
入选标准
- •Patients 18 years old and above
- •English speaking
- •patients with capacity to consent
- •Elective laparoscopic and robotic benign genecology cases
- •Elective laparoscopy/ robotic hysterectomy
- •Elective laparoscopy/robotic myomectomy
- •ERAS (enhanced recovery after surgery) protocol applied
排除标准
- •Pregnant women
- •patients with positive urine pregnancy test in pre operative
- •emergency procedures
- •Procedure requiring staging or debulking
- •surgeries that convert to laparotomy
- •patients with allergy to local/systemic anaesthesia or analgesia
- •Inability to undergo normal anesthesia induction process
- •ASA III or higher
- •history of pain relief medication dependence
- •history of substance abuse
- •end stage chronic kidney disease
- •advanced liver disease
- •history of chronic pain
- •history of taking opioids or neuropathic agents regularly prior to surgery
- •BMI of 50 or over
- •skin infections at the site of TAP block injection or port sites.
研究组 & 干预措施
Laparoscopic assisted TAP block
Laparoscopic assisted TAP block will be done by surgeon intra-operatively
干预措施: TAP block with liposomal bupivacaine and bupivacaine (Drug)
结局指标
主要结局
pain scores at 24 hours in LA-TAP and NO TAP block groups
时间窗: 24 hour post op
numeric pain score (NPS)pain scores at 24 hours will include the average pain score at rest reported by the patient in the first 24 hours.
Amount and type of opioid consumption , based on Questionnaire's information . between LA-TAP , UG-TAP and No TAP groups at 24 hours post operatively
时间窗: 24 hour post op
MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time.
次要结局
- Numeric pain score (NPS) based on questionnaire's information at 48 hours & 72 hours post operatively , in LA-TAP , UG-TAp and no TAP groups(48 -72 hour post operative)
- amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ?(48 -72 hours post operative)
- Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op(first 72 hours post operative)