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临床试验/CTRI/2025/02/080750
CTRI/2025/02/080750尚未招募4 期

Comparison of the effectiveness of ultrasound guided bilateral external oblique intercostal plane block and subcostal transversus abdominis plane block for post operative analgesia management after laparoscopic cholecystectomy- Randomised double blinded study.

Chettinad hospital and research institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare the requirement of tramadol

研究概览

简要总结

To compare the effectiveness of ultrasound guided Bilateral external oblique intercostal plane block,  subcostal transversus abdominis plane block - a randomized double blinded study.PRIMARY OBJECTIVES

To compare the requirement of tramadol in first 24 hours.

SECONDARY OBJECTIVES

To compare the hemodynamic stability between the study groups

To compare the quality of recovery index of the groups.

To compare the intensity of using VAS score.

Inclusion criteria :

1)Age - 18-65 years.

2)American society of anesthesiologist (ASA) grade – I,II,III

Exclusion criteria :

1)Patient refusal.

2)Age - < 18, > 65 years of age.

3)Local infection at the site of block.

4)When laparoscopic surgery converted to open.

5)Abnormal coagulation profile.

METHODOLOGY

1)Study design: Prospective, randomised, double blinded, case study.

2)Study population: After obtaining approval by the institutional ethics committee and CTRI registration, written and informed patient consent, 20 patients on each group under ASA physical status I,II,III patients scheduled for laparoscopic cholecystectomy at Chettinad Hospital and Research Institute, Kelambakkam, Chennai.

3)Sample size: Sample size is calculated using the formula for difference in means with alpha error of 5% and power 80% using data from the study of Saudi medical journal- Muhammet korkusuz, Betul basaran, Tayfun et, Aysegul bilge, Rafet yarimoglu, Hasan Yildirim. Biateral external oblique intercostal plane block in patients undergoing laparoscopic cholecystectomy. 2023;10: 1037-1045- 20 per group.

PREOPERATIVE ASSESSMENT:

-Detailed history and physical examination, baseline data like HR,BP and basic investigations will be collected.

-An IV access with 18G IV cannula will be secured for all patients.

-Premedication such as Tab Pantoprazole 40mg and Tab Anxit 0.5mg given a night before surgery and 6 am on the day of surgery.

INTRA-OPERATIVE ASSESSMENT:

-Proper standard monitoring of SpO2, NIBP, ECG will be established and baseline variable values will be noted before the procedure.

-Patient will undergo GA induction with IV propofol 2mg/kg, IV fentanyl 1-2mcg/kg, IV atracurium 0.5-0.7mg/kg.

-Tracheal intubation was then performed approximately 3 mins after anesthesia induction.

-Mechanical ventilation was conducted using Volume controlled mode with a tidal volume of 6-8 ml/kg, resulting in an end tidal CO2 pressure range of 35-40 mmHg.

EOIPB group:

-EOIPB was administered following the intubation.

-The high frequency linear US probe will be covered with a sterile sheath, and an 80 mm block needle will be used.

-A linear USG transducer was positioned in the sagittal plane at the 6TH rib level between the anterior axillary and mid clavicular lines.

-The ribs , lungs, pleura, intercostal muscle, external oblique muscle and subcutaneous tissue was visualized in the image.

-EOIB is performed under US guidance is a block by injection of LA between the external and internal oblique muscles.

-The in- plane technique with a 22G, 80mm block needle, after negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed.

-Once the block location is confirmed, 20ml of 0.25% bupivacaine will be injected bilaterally.

Subcostal TAPB group:

-TAPB was administered following the intubation.

-The US probe will be placed in the sagittal direction on the 10th costal margin in the midline and a deep angle was given to costochondral angle, and the external oblique abdominal muscle, internal oblique abdominal muscle, and the transverse abdominis muscle will be visualized.

-Then, using the in-plane technique, the needle will be advanced with the help of ultrasound until the needle tip reaches the space between the internal oblique and transverse abdominis muscles.

-After negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed.

-Once the block location is confirmed, 20ml of 0.25% bupivacaine will be injected bilaterally.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1.American Society of Anesthesiologist (ASA) grade I-III.2.Age 18-65 years.

排除标准

  • 1.when laparoscopy converted to open.
  • Age >18 or above
  • 3.Patient refusal.
  • 4.Local infection at the site of infection.
  • Abnormal coagulation profile.

结局指标

主要结局

To compare the requirement of tramadol

时间窗: First 24 hours

次要结局

  • To compare hemodynamic stability, quality of recovery index of the group, intensity of pain using VAS score.(First 24 hours)

研究者

发起方
Chettinad hospital and research institute
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Akshaya G

Chettinad hospital and research institute

研究点 (1)

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