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临床试验/CTRI/2025/12/098911
CTRI/2025/12/098911尚未招募2/3 期

Comparison Of Post-Operative Recovery In Single Puncture Subcostal Transversus Abdominis Plane And Rectus Sheath Block With Erector Spinae Plane Block In Patients Undergoing Laparoscopic Cholecystectomy-A Randomized Controlled Study.

Bhagat Phool SINGH Govt Medical College1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年12月22日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
To compare the Quality of recovery after single puncture subcostal transversus abdominis plane and

研究概览

简要总结

Laparoscopic cholecystectomy is considered the gold standard of therapy for symptomatic cholelithiasis

and despite recent advances, majority of the patients still experience poor quality of recovery and pain in

the postoperative period. Untreated postoperative pain has many consequences, including patient

dissatisfaction, transition into chronic pain, delayed discharge from the hospital and increased healthcare

costs. This study aims to compare the post-operative quality of recovery in unilateral Erector Spinae

Block (ESB) versus unilateral single puncture subcostal transversus abdominis plane block and Rectus

sheath block. The study utilizes ropivacaine due to its reversible inhibition of nerve impulses, resulting

in prolonged sensory blockade at lower doses and fewer side effects like cardio-toxicity. Real-time

ultrasound is employed for precise imaging of abdominal wall muscular layers, ensuring accurate needle

placement and local anaesthetic injection, enhancing the efficacy and safety of the block.

The study employs the Quality of Recovery-15 (QoR-15 H), a validated patient-reported outcome

measure, to assess postoperative quality of recovery. This measurement has been found valid, reliable,

and responsive in surgical patients, meeting the requirements for outcome measurement instruments in

clinical trials.

This study also evaluates the duration of postoperative analgesia based on the demand for the, first rescue

analgesia, reduction in total doses of postoperative rescue analgesia, pain scores, and potential side effects

and complications.

Patient will be randomly divided into two groups with 50 patients in each group. Group ES will receive

30 ml of 0.25% isobaric ropivacaine unilaterally in plane below the erector spinae muscle before starting

of surgery. Group TR will receive 20ml of 0.25 % isobaric ropivacaine, unilaterally into plane between

the transversus abdominis and internal oblique muscles and 10ml of 0.25%isobaric ropivacane into plane

between rectus muscle and posterior rectus sheath before starting of the surgery.

Patient will be observed for quality of recovery and duration of postoperative analgesia by time to first

rescue analgesic after ultrasound guided Erector spinae plane block or subcostal transversus abdominis

plane and rectus sheath block in laparoscopic cholecystectomy. The Quality of recovery will be assessed

in patients using QoR-15 H score at 24 hrs, requirement of rescue analgesics in the first 24 hours

postoperatively, the hemodynamic changes perioperatively, any side effects in both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient posted for Laparoscopic cholecystectomy under general anaesthesia Patient in the age group 18-65 years, of any gender Patients with American society of Anaesthesiologists physical status I or II.

排除标准

  • Patient’s refusal to participate in the study.
  • History of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic diseases.
  • Patient with any coagulopathy.
  • History of allergy to drugs under study.
  • Infection at regional block site.
  • Patients inability to understand QOR-15 questionnaire.

结局指标

主要结局

To compare the Quality of recovery after single puncture subcostal transversus abdominis plane and

时间窗: 24 hours

rectus sheath block versus erector spinae plane block in patients undergoing laparoscopic

时间窗: 24 hours

cholecystectomy under general anaesthesia.

时间窗: 24 hours

次要结局

  • To compare the analgesic requirements in the 1st 24-hours post-operative period in terms of pain scores,(times of first rescue analgesic dosage, & total analgesic consumption in both the groups.)

研究者

发起方
Bhagat Phool SINGH Govt Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

NAVNEET

BPS GMC KHANPUR KALAN SONIPAT

研究点 (1)

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