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CTRI Number  CTRI/2024/08/072020 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Pain Relief and Opioid Use After Laparoscopic Gallbladder Surgery: Ultrasound-Guided Nerve Blocks -Bilateral intertransverse nerve block versus Bilateral erector spinae nerve block. 
Scientific Title of Study   Comparison of postoperative analgesia and opioid consumption in ultrasound guided bilateral intertransverse process block versus bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy 
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 Nikitha A 
Designation  Primary DNB Anaesthesia resident 
Affiliation  ASTER CMI HOSPITAL,HEBBAL 
Address  2nd floor,Department of anaesthesia, Aster CMI Hospital #43/2, New airport road, NH 7 Sahakara nagar, Hebbal Bengaluru-560092

Bangalore
KARNATAKA
560092
India 
Phone  9740687521  
Fax    
Email  nikithaanoop@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurang J Kothari 
Designation  Consultant 
Affiliation  ASTER CMI HOSPITAL,HEBBAL 
Address  2nd floor,Department of anaesthesia, Aster CMI Hospital #43/2, New airport road, NH 7 Sahakara nagar, Hebbal Bengaluru-560092

Bangalore
KARNATAKA
560092
India 
Phone  8105885778  
Fax    
Email  Gaurangkothari29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vyshali Dharmapal 
Designation  Consultant  
Affiliation  ASTER CMI HOSPITAL,HEBBAL 
Address  2nd floor,Department of anaesthesia, Aster CMI Hospital #43/2, New airport road, NH 7 Sahakara nagar, Hebbal Bengaluru-560092

Bangalore
KARNATAKA
560092
India 
Phone  9845219195  
Fax    
Email  vyshalidharmapal@gmail.com  
 
Source of Monetary or Material Support  
Aster CMI Hospital #43/2, New airport road, NH 7 Sahakara nagar, Hebbal Bengaluru-560092  
 
Primary Sponsor  
Name  Dr Nikitha A 
Address  DNB resident,department of anaesthesia,Aster CMI Hospital #43/2, New airport road, NH 7 Sahakara nagar, Hebbal Bengaluru-560092 
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 Nikitha A  Aster CMI Hospital  Department of anaesthesia,2nd floor,Aster CMI hospital, #43/2, New Airport road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
Bangalore
KARNATAKA 		 9740687521

nikithaanoop@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional ethics committee of Aster CMI Hospital ,Banglore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bilateral erector spinae plane block   One group will receive ultrasound guided bilateral erector spinae plane block using 60 ml 0.125% bupivacaine post surgery under general anaesthesia 
Comparator Agent  Bilateral intertransverse process block   One group will receive ultrasound guided bilateral intertransverse process block using 60 mL 0.125% bupivacaine post surgery under general anaesthesia  
Intervention  Ultrasound guided bilateral intertransverse process block versus bilateral erector spinae plane block  In this study, patients undergoing laparoscopic cholecystectomy will be divided into two equal groups, one group receiving ultrasound guided intertransverse process block using 0.125% bupivacaine and the other group receiving ultrasound guided erector spinae block using 0.125% bupivacaine. Intraoperatively the two groups will receive fentanyl 2mcg/cc, loading dose of dexmedetomidine 0.5 mcg/kg in 10 minutes and maintenance dose of 0.2-0.3mcg/kg/hr. till the end of surgery, paracetamol 1 Gram and inj diclofenac 75 milligrams. Their requirement of rescue analgesics , postoperative analgesics and opioid consumption in terms of morphine equivalence will be recorded over 36 hrs or till the discharge whicherver is early. Thus analgesic efficacy of both blocks can be assessed and thus will help in effective postoperative pain management in patients undergoing laparoscopic cholecystectomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients undergoing laparoscopic cholecystectomy above 18 years belonging to ASA1,ASA2 and ASA 3 Category. 
 
ExclusionCriteria 
Details  1)ASA IV patients
2)Coagulopathy
3)Patient refusal
4)History of allergy to LA
5)Contraindication to any analgesics
6)Chronic pain disorders
7)Infection at the injection site
8)Pregnancy
9)Neurological cognitive disorder
10)Patients on anticoagulants
11)Acute abdomen
12)Coincidental surgeries
13)Patients with surgical drain
14)Gall bladder adhesions

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Compare the postoperative visual analogue scale in laparoscopic cholecystectomy in patients receiving intertransverse process plane block and erector spinae plane block using 0.125% bupivacaine  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1)To measure and compare the consumption of opioid rescue analgesic and postoperative analgesics in terms of morphine equivalence over 36 hr postoperative period or till discharge whichever is earlier between two groups.   2 years 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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 3 
Date of First Enrollment (India)   20/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nikithaanoop@gmail.com].

  6. For how long will this data be available start date provided 21-12-2026 and end date provided 21-12-2042?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Erector spinae plane block and intertransverse process block are regional analgesic techniques that are the latest developments in postoperative pain therapy. Both techniques are used for pain relief  after mastectomy, thoracic ,abdominal and spinal surgery and are found effective due to their simplicity and lower risks compared to epidural analgesia1. The aim of the study is to compare the effect of ultrasound guided bilateral intertransverse process block versus bilateral ultrasound guided erector spinae plane block on postoperative analgesia and the opioid consumption in terms of morphine equivalence in patients undergoing laparoscopic cholecystectomy under general anesthesia by a prospective randomized double blind trial.

In this study, patients undergoing laparoscopic cholecystectomy will be divided into two equal groups, one group receiving ultrasound guided intertransverse process block using 0.125% bupivacaine and the other group receiving ultrasound guided erector spinae block using 0.125% bupivacaine. Intraoperatively the two groups will receive fentanyl 2mcg/cc, loading dose of  dexmedetomidine 0.5 mcg/kg in 10 minutes and maintenance dose of 0.2-0.3mcg/kg/hr. till the end of surgery, paracetamol 1 Gram and inj diclofenac 75 milligrams. Their requirement of rescue analgesics , postoperative analgesics and opioid consumption in terms of morphine equivalence will be recorded over 36 hrs. Thus analgesic efficacy of both blocks can be assessed and thus will help in effective postoperative pain management in patients undergoing laparoscopic cholecystectomy.


 
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