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临床试验/NCT04037878
NCT04037878已完成不适用

Opioid Consumption Following TAP Block Versus Intraperitoneal/Incisional Bupivicaine in Patients Undergoing Major Gynecologic Surgeries: A Randomized Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2017年11月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Total consumption of tramadol

研究概览

简要总结

It is a randomized controlled trial to determine the total tramadol consumption after major gynecological studies. Intervention groups include TAP block or local infiltration by the surgeon. These will be compared to a control group. Total tramadol consumption will be calculated and therefore pain control will be assessed.

详细描述

All patients will receive standardized general anesthetic with standard monitoring. Anesthesia will be induced with intravenous (IV) tramadol (1milligram/kg), propofol (2 mg/kg) and atracurium 0.5mg/kg. Anaesthesia will be maintained with oxygen/air (40:60) with one MAC(Minimum Alveolar Concentration) of isoflurane.

TAP block will be performed for Group T patients before surgical incision with the help of an ultrasound and will be performed by two of the anesthesiologists who are part of this study. The study drug for the TAP block will be two syringes of 20 ml containing bupivacaine 0.25% with no other additives. For the infiltration group I, a 50ml syringe will contain 25ml of 0.5% Bupivacaine and 25ml of 5mics/ml epinephrine. These solutions will be made there and then by the anesthesiologist and the drugs for these solutions will be provided by the clinical trial unit. Allocation to group T, I and C will be according to the randomization block explained earlier. For group T, the US-guided TAP block technique will be similar to the method described by Hebbard and colleagues; (21) an ultrasound linear probe will be positioned in the mid-axillary line in the axial plane half-way between the iliac crest and the costal margin. Transversus abdominal plain will be located under ultrasound guidance. One ml test injection of the study solution will be permitted to confirm needle location. A total of 20ml of study solution will be injected on each side after aspiration to avoid intravascular placement. Surgical incision will be given after 20 minutes of TAP. Additional doses of Tramadol 10mg IV stat will be given on need basis (Rise of heart rate and blood pressure more than 20 % of baseline).

Towards the end of surgery, 50 ml of solution prepared by the anesthesiologist will be used for Group I. 50ml of 0.25% Bupivicaine with epinephrine will be poured into a sterile galley pot, from which the surgeon will draw up the solution. The surgeon will be asked to spray 10ml of this solution on to the pouch of Douglas, 10ml in the peritoneum, 10ml in the rectus sheath and 20ml in the skin.

The amount of Bupivicaine used for group I and T is less than the maximum safe dose which is 2.5mg per kg. Minimal side effects are reported using an ultrasound guided TAP block technique(22). If an immediate side effect is noted while performing the technique, treatment will be administered and the patient will be withdrawn from the study.

The control group (C) will receive the standard anesthesia and analgesia as mentioned above without any nerve block technique.

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
Double (Participant, Investigator)

盲法说明

The patient is randomized according to randomization block and sealed envelops. The investigator doesn't know what study group the patient is randomized into

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Weight between 40 and 90kg
  • ASA(American Society of Anesthesiologists) I to III
  • Females scheduled for major gynecological surgeries(Abdominal hysterectomy, myomectomy, ovarian cystectomy, oophorectomy) through Pfannenstiel incision

排除标准

  • Refusal to participate in the study,
  • History of drug allergy to bupivacaine, tramadol or other narcotics, addiction/ tolerance to opioids,
  • Having bleeding disorders,
  • Abdominal skin infections or open wounds/ abdominal drains,
  • Previous history of failed TAP block,
  • On blood thinners or narcotic analgesia

研究组 & 干预措施

TAP block group

Experimental

Patients in this arm will be given Transversus Abdominal Plane(TAP) block after the induction of anesthesia. They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol.

干预措施: Transversus Abdominis Plane Block(TAP Block) (Procedure)

TAP block group

Experimental

Patients in this arm will be given Transversus Abdominal Plane(TAP) block after the induction of anesthesia. They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol.

干预措施: PCIA Tramadol (Drug)

Local infiltration

Experimental

Patients in this arm will be given local and intraperitoneal infiltration of local anesthetic before closure.They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol.

干预措施: Intra-peritoneal infiltration (Procedure)

Local infiltration

Experimental

Patients in this arm will be given local and intraperitoneal infiltration of local anesthetic before closure.They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol.

干预措施: PCIA Tramadol (Drug)

Control group

Other

These patients will be given post operative analgesia in the form of patient controlled intravenous analgesia(PCIA) using tramadol. Neither local infiltration nor TAP block will be administered

干预措施: PCIA Tramadol (Drug)

结局指标

主要结局

Total consumption of tramadol

时间窗: 12 hours post operatively

Total consumption of tramadol post operatively

次要结局

  • Pain score(12 hours post operatively)
  • Respiratory depression(12 hours post operatively)
  • Nausea(12 hours post operatively)
  • Sedation(12 hours post operatively)
  • Patient satisfaction(12 hours post operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samina Ismail

Professor of Anesthesiology

Aga Khan University

研究点 (1)

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