| CTRI Number |
CTRI/2025/02/080750 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study comparing bilateral external oblique intercostal plane block and subcostal transversus abdominis plane block to prevent post operative pain in laparoscopic cholecystectomy patients |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshaya G |
| Designation |
Postgraduate resident - MD Anesthesiology |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Dr Akshaya G, Postgraduate resident, Department of anesthesiology, Chettinad hospital and research institute,chettinad health city, rajiv gandhi salai(OMR), kelambakkam,Tamilnadu 603103
Kancheepuram TAMIL NADU 603103 India |
| Phone |
8870455755 |
| Fax |
|
| Email |
akshayajothi14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Merlin Shalini Ruth |
| Designation |
Professor |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Professor, Department of Anesthesiology, Chettinad hospital and research institute,chettinad health city, rajiv gandhi salai(OMR), kelambakkam,Tamilnadu 603103
Chennai TAMIL NADU 603103 India |
| Phone |
9790983957 |
| Fax |
|
| Email |
merlin5shalini@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Akshaya G |
| Designation |
Postgraduate resident - MD Anesthesiology |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Dr Akshaya G, Postgraduate resident, Department of anesthesiology, Chettinad hospital and research institute,chettinad health city, rajiv gandhi salai(OMR), kelambakkam,Tamilnadu 603103
Chennai TAMIL NADU 603103 India |
| Phone |
8870455755 |
| Fax |
|
| Email |
akshayajothi14@gmail.com |
|
|
Source of Monetary or Material Support
|
| chettinad hospital and research institute, chettinad health city, rajiv gandhi salai, kelambakkam, chennai, tamilnadu, india-603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute, Chettinad Health City, rajiv gandhi salai, Kelambakkam, Tamilnadu 603103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshaya G |
Chettinad hospital and research institute |
D- block, 1st floor, Department of Anesthesiology, chettinad health city, rajiv gandhi salai, kelambakkam, chennai, tamilnadu, India - 603103 Chennai TAMIL NADU |
8870455755
akshayajothi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committe For Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External oblique intercostal plane block following endotracheal intubation |
External oblique intercostal plane block using 20 ml of 0.25% Bupivacaine followed by endotracheal intubation for postoperative pain management in patients undergoing laparoscopic cholecystectomy and will be assessed postoperatively for the next 24 hours. |
| Intervention |
ultrasound guided subcostal transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy |
Subcostal transverse abdominis plane block using 20 ml of 0.25% Bupivacaine followed by endotracheal intubation for postoperative pain management in patients undergoing laparoscopic cholecystectomy and will be assessed postoperatively for the next 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologist (ASA) grade I-III.2.Age 18-65 years.
|
|
| ExclusionCriteria |
| Details |
1.when laparoscopy converted to open. 2. Age >18 or above 65. 3.Patient refusal. 4.Local infection at the site of infection. 5. Abnormal coagulation profile. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the requirement of tramadol |
First 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic stability, quality of recovery index of the group, intensity of pain using VAS score. |
First 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |