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临床试验/CTRI/2024/03/063653
CTRI/2024/03/063653尚未招募Phase 3 4

BILATERAL QUADRATUS LUMBORUM BLOCK COMPARING POSTERIOR VS ANTERIOR APPROACH FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY

GMERS Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月16日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
The time to the requirement of first rescue analgesia

研究概览

简要总结

AIM OF STUDY

To compare postoperative analgesic duration of ultrasound guided Two types of QL block (posterior QL  Vs Anterior QL) using inj. Ropivacaine 0.25% in laparoscopic cholecystectomy surgeries

OBJECTIVES

PRIMARY OBJECTIVE

·       To compare the duration of post operative analgesia of ultrasound guided bilateral two type of QL block with  inj. Ropivacaine (0.25%)

 SECONDARY OBJECTIVE

Total consumption of systemic analgesics 24 hour postoperatively

Ease of administration of two blocks

Safety of block

Patient’s satisfaction score

 STUDY PROTOCOL

ETHICAL CONSIDERATION: this study will be conducted after obtaining ethical approval by local ethical committee of GMERS MEDICAL COLLEGE AND HOSPITAL, Vadodara and topic being registered with CTRI (clinical trial registry of India)

STUDY DESIGN: Prospective Randomized control, double blind clinical study with allocation concealment and a uniform allocation sequence

STUDY PLACE: General surgery operating unit in a tertiary care teaching hospital( GMERS Medical college and Hospital, Vadodara)

STUDY PERIOD: over the period 6-10 months after the approval from ethical committee

STUDY POPULATION: Adults consenting for administration of QL block posted for laparoscopic cholecystectomy surgery with comparable demographic profile

 INCLUSION CRITERIA:

Patients posted for laparoscopic cholecystectomy surgery consenting for administration of QL block post operatively

patients aged between 18 to 60 years

patients with BMI ranging between 19- 30 kg/m2

patients with American society of anesthesia physical status I and II

  EXCLUSION CRITERIA:

Infection at local site

History of allergic reaction to study drugs

Patients on chronic pain medication

Altered coagulation profile

History of known lower limb muscle weakness

Known systemic disease pertaining CVS, Respiratory, psychiatric, central nervous system, renal, liver, musculoskeletal system

METHODOLOGY

After proper informed written consent, patients of ASA- I & II physical status posted for Laparoscopic cholecystectomy Surgeries will be recruited to participate in the study To ensure equality of randomization, each patient will be randomly assigned after considering inclusion/exclusion criteria, using concealed opaque envelope method by consultant in Department of Anesthesia, into either

Group P: Posterior Quadratus lumborum muscle block

Group A: anterior Quadratus lumborum muscle block

 The study will be single blinded randomized clinical study with Patient receiving block  will be blinded to the type of block

METHOD

Thorough preanesthetic Evaluation done prior to day of surgery to give the final fitness Following the routine protocol for General Anesthesia, patient will be anesthetized under General Anesthesia after proper premedication, routine induction agent and muscle relaxant, securing the airway with endotracheal tube and maintained preoperatively with mechanical ventilation  At the end of the surgery QL block will be administered under USG guidance (low frequency curvilinear probe of 3-5 Hz) bilaterally by a trained Anesthesiologist. Inj. paracetamol 1 gm iv given half hour before extubation

 USG GUIDED ANTERIOR QUADRATUS LUMBORUM BLOCK

·       The procedure will be performed bilaterally on each patient in lateral position under all aseptic and antiseptic precaution The transducer will be placed transverse position cranial to iliac crest at the level of posterior axillary line The needle will be inserted in plane from posterior to anterior trajectory until needle tip penetrated in anterior part of QL muscle 20 ml of 0.25% inj. Ropivacaine will be injected after negative aspiration of blood between the QL and psoas muscle

 USG GUIDED POSTERIOR QUADRATUS LUMBORUM BLOCK

The procedure will be performed bilaterally on each patient in lateral position under all aseptic and antiseptic precaution. The transducer will be placed transverse position cranial to iliac crest at the level of posterior axillary line The needle will be inserted in plane from posterior to anterior trajectory until needle tip  penetrated posterior to QL muscle inj. Ropivacaine (0.25%) 20 ml will be injected posterior to the lateral edge of the QL muscle, between QL muscle and erector spinae muscle within the middle layer of thoracolumbar fascia after negative aspiration of blood

Procedure Time will be noted from time of inserting needle on one side to removal of needle on the contralateral side after administration of block Patient will be shifted to PACU for observation

ASSESSMENT OF ANALGESIA:

The analgesic effect of block will be assessed using VAS score at rest (end of surgery 30th minute, 2nd , 6th , 12th and 24th hour), during activity up to 24 hours by an observer who is blinded to the type of block given

If any point of time VAS is more than equal to 4 inj. Tramadol 100 mg intravenously will be given as rescue analgesia there after inj. tramadol 100 mg will be administered round the clock till 24 hours of observation. Total duration of analgesia will be considered from T0 (time of completion of administration of QL block) to first rescue analgesia will be given Total consumption of rescue analgesic drug during the period observation will be documented

OUTCOME MEASURES

PRIMARY OUTCOME: The time to the requirement of first rescue analgesia observed in the study groups becomes the primary outcome of this study

SECONDARY OUTCOME: The total consumption of analgesics in postoperative period up to 24 hours forms the secondary outcome Also the difference in duration of procedure time and Patient’s vital parameters stability and patient satisfaction score graded as poor, fair, Good, excellent will be observed till 24 hours

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for laparoscopic cholecystectomy surgery consenting for administration of QL block post operatively 2)Patients aged between 18 to 60 years 3)Patients with BMI ranging between 19-30 kg per m2 4)Patients with American society of anaesthesia physical status I and II.

排除标准

  • Infection at local site 2)History of allergic reaction to study drugs 3)Patients on chronic pain medication 4)Altered coagulation profile 5)History of known lower limb muscle weakness 6)Known systemic disease pertaining CVS, Respiratory, psychiatric, central nervous system, renal, liver, musculoskeletal system.

结局指标

主要结局

The time to the requirement of first rescue analgesia

时间窗: The time to the requirement of first rescue analgesia observed in the study groups via visual analogue score at rest(end of surgery 30 minutes, 2nd, 6th, 12th, 24th hour)

次要结局

  • The total consumption of analgesics in postoperative period
  • the difference in duration of procedure time(the difference in duration of procedure time in minutes)
  • Patient’s vital parameters stability(Patient’s vital parameters stability till 24 hours)
  • patient satisfaction score(patient satisfaction score till 24 hours)

研究者

发起方
GMERS Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DALAL PRACHI KALPESHKUMAR

GMERS Medical College & hospital Gotri Vadodara

研究点 (1)

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