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临床试验/NCT06803966
NCT06803966已完成2 期

Comparison of Rescue Analgesia Requirement After Transversus Abdominal Plane (TAP) Block Vs Local Anesthetic Wound Infiltration After Laparoscopic Cholecystectomy

Fazaia Ruth Pfau Medical College1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年8月5日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
first rescue analgesia

研究概览

简要总结

patients undergoing laparoscopic cholecystectomy will be diveided into 2 groups A & B . Group A will receive local anesthetic wound infiltration and group B will receive Transversus abdominal plane block as a post operative analgesia. the time for request of first rescue analgesia between the 2 groups will be compared

详细描述

After acquiring approval from Institutional Review Board, the work on the study will begin. The patients planned to undergo elective laparoscopic cholecystectomy first appear for pre-anesthesia assessment and here all relevant baseline tests and demographics (age, weight, ASA score, co morbid and allergies) will be recorded. The patient meeting the inclusion criteria will be explained about the study in the language they understand, its benefits, risks and any other relevant queries will be heard and answered. Those willing to participate will be enrolled into the study, after written consent. Confidentiality of the study subjects will be assured throughout. Data will only be accessible to the principal investigator.

Patients will be assigned either in Group A or Group B using sequentially numbered opaque sealed envelope protocol. Both patients and study investigators will be blinded to study groups. Only an anesthetist who will prepare the medication and will not be part of this study, will have correct knowledge of group identification.

On the day of operation, after patient is shifted to the operating room, monitors will be attached and vitals including Blood pressure, heart rate, mean arterial blood pressure, SpO2 and ETCO2 will be continuously monitored. Patient will be pre medicated by 0.1 mg/kg nalbuphine. For induction of anesthesia, 2 mg/kg propofol and 0.5 mg/kg Atracurium as a relaxant will be given. Anesthesia will be maintained on Isoflurane. Before the start of procedure NG tube will be inserted.

At the end of surgery before extubating, Injection ondansetron 0.15 mg/kg IV will be given to the patient. Next, as patients will be divided into two groups via closed envelope method, Group A will get local anesthetic wound infiltration and group B will receive TAP block. Local Anesthetic infiltration will be given with 20ml of 0.5% bupivacaine (5ml at each port site). TAP block will be given as 0.25% bupivacaine 20ml on each side, using ultrasound guidance.

After extubation, patient will be shifted to post surgical ward where they will be kept under close monitoring. Pain status will be monitored using the NRS at following hours 0, 2, 4, 8, 12, 24 and/or when patient complains. Rescue analgesia will be given by injection Toradol as 30 mg IV, when patient categorizes the pain as 4 or more according to NRS. This time at which rescue analgesia is given will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •both gender patients undergoing elective laparoscopic cholecystectomy ASA physical status classification 1 & 2

排除标准

  • •patients with chronic pain patients unable to understand NRS pain scale conversion of laparoscopic to open cholecystectomy

研究组 & 干预措施

Group A: local anesthetic infiltration at port sites

Active Comparator

Group A patient's will receive local anesthetic wound infiltration at port sites with inj Bupivacaine (Bupivacaine Hydrochloride) 0.5%

干预措施: Post Operative Analgesia (Other)

Group B : TAP block

Active Comparator

Group b will receive Transversus Abdominal Plane (TAP) block at both sides using inj bupivacaine (Bupivacaine Hydrochloride) 0.25%

干预措施: Post Operative Analgesia (Other)

结局指标

主要结局

first rescue analgesia

时间窗: from enrollment to 24 hours post operation

time of requirement of first rescue analgesia will be compared between group a and group b

次要结局

未报告次要终点

研究者

发起方
Fazaia Ruth Pfau Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sumbul Andleeb

Principal Investigator

Fazaia Ruth Pfau Medical College

研究点 (1)

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