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CTRI Number  CTRI/2024/07/071473 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare between ultrasound guided erector spinae plane block and oblique subcostal transversus plane block pain control in patients after laparoscopic cholecystectomy 
Scientific Title of Study   Comparative study of the efficacy of ultrasound guided erector spinae plane block and oblique subcostal transversus abdominis plane block for post operative analgesia after laparoscopic cholecystectomy.A randomized clinical trial 
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 Subu Kobing 
Designation  Post graduate trainee 
Affiliation  RIMS Imphal 
Address  Department of Anaesthesiology RIMS Imphal
A sector Naharlagun, Near Rajdhani petrol pump Distt Papumpare State Arunachal Pradesh
Imphal West
MANIPUR
795004
India 
Phone  6909021993  
Fax    
Email  kobingsubu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kh Maniram Singh 
Designation  Professor 
Affiliation  RIMS Imphal 
Address  Department of Anaesthesiology RIMS Imphal
Department of Anaesthesiology RIMS Imphal
Imphal West
MANIPUR
795004
India 
Phone  8259055986  
Fax    
Email  drmram6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Subu Kobing 
Designation  Post graduate trainee 
Affiliation  RIMS Imphal 
Address  Department of Anaesthesiology RIMS Imphal
A sector Naharlagun Near Rajdhani petrol pump Distt Papumpare State Arunachal Pradesh
Imphal West
MANIPUR
795004
India 
Phone  6909021993  
Fax    
Email  kobingsubu@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur 795004 India 
 
Primary Sponsor  
Name  SUBU KOBING 
Address  Regional Institute of Medical Sciences Imphal Manipur 795004 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SUBU KOBING  Regional Institute of Medical Sciences Imphal West,Manipur  Elective surgery Operation theatre complex (OT number 1 to 8) Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West Manipur 795004 India
Imphal West
MANIPUR 
6909021993

kobingsubu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board,Regional Institute of Medical Sciences,Imphal,Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Comparator Agent  Ultrasound-guided Erector Spinae Plane block  Study Participants will be divided into two groups. Intervention Group A will be given Erector Spinae Plane Block at the level of T9 vertebra with 40ml of 0.25% Levobupivacaine after Laparoscopic Cholecystectomy and patients will be followed up for 24 hours after the intervention. 
Intervention  Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block   Study Participants will be divided into two groups. Intervention Group B will be given Oblique Subcostal Transversus Abdominis Plane Block with 40ml of 0.25% Levobupivacaine just below the costal margin after Laparoscopic Cholecystectomy and the patient will be followed up for 24 hours after the intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of age 18-70 years with ASA(American Society of Anaesthesiologists)Grade 1 and Grade 2
2.Patients with BMI between 18-30 
 
ExclusionCriteria 
Details  1.Patients refusal
2.Patients with known allergy to local anaesthesia
3.Patients with bleeding diathesis,presence of severe kidney,hepatic disease,on anticoagulants,pre-existing cardiovascular disease,chronic opioid consumption,severe or advanced psychiatric illness.
4.Patients with previous upper abdominal surgery,any deformity in spine
5.Patients with infection at the regional block site 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate for pain using Numerical Rating Score(NRS)  Outcome will be assesed at 0 hour,3rd,6th,9th,12th,18th and 24th hour after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate total analgesic consumption and time to first rescue analgesia and postoperative nausea and vomiting  Outcome will be assesed from the time of intervention and data will be collected at the end of 24 hour 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   10/08/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Laparoscopic Cholecystectomy is a minimally invasive surgery, which is the procedure of choice for the majority of patients with gallbladder pathologies. Intraoperative access is provided with small keyhole entries on abdominal wall. Laparoscopic Cholecystectomy causes moderate to severe postoperative pain which has different components; incisional pain from the trocar site(somatic pain),and local visceral pain(deep abdominal pain).Many patients also suffer from shoulder pain which is due to subdiaphragmatic irritation, transmitted by phrenic nerve referred to C4 dermatome. Multimodal approaches with NSAIDS, dexamethasone, gabapentinoids, opioids, local anesthetic infiltration to port sites, epidural analgesia have been tried to attenuate postoperative pain after Laparoscopic Cholecystectomy. Inadequate postoperative pain control has many consequences ,including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, increased healthcare costs etc. Hence, adequate Postoperative Pain Management(POPM) should be major issue and challenge for the anesthesiologists. Ultrasound-guided oblique subcostal transversus abdominis plane block(OSTAP)  blocks somatic pain fibers and the deeper fibers of the anterior and lateral cutaneous branches of the 9th to 11th thoracic intercostal nerves. Ultrasound-guided erector spinae plane block (ESPB) is a relatively new technique used for analgesia. It targets the ventral rami, dorsal rami, and rami communicantes of the spinal nerves and thus results in the blockage of both somatic and visceral pain. Our study aimed to compare these two blocks using low concentration of Local anesthetic (0.25% Levobupivacaine).

 
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