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CTRI Number  CTRI/2025/12/098911 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Different blocks in Laparoscopic Cholecystectomy Patients. 
Scientific Title of Study   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. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAVNEET 
Designation  DNB RESIDENT  
Affiliation  BPS GMC KHANPUR KALAN SONIPAT  
Address  DEPARTMENT OF ANAESTHESIOLOGY Bhagat Phool Singh govt Medical College KHANPUR KALAN SONIPAT
DEPARTMENT OF ANAESTHESIOLOGY Bhagat Phool Singh govt Medical College KHANPUR KALAN SONIPAT
Sonipat
HARYANA
131305
India 
Phone  8307008945  
Fax    
Email  dhillonnavneet2222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MEENA SINGH 
Designation  Associate Professor MBBS,MD (ANAESTHESIOLOGY) 
Affiliation  BPS GMC KHANPUR KALAN SONIPAT  
Address  DEPARTMENT OF ANAESTHESIOLOGY, BHAGAT PHOOL SINGH GOVERNMENT MEDICAL COLLEGE KHANPUR KALAN SONIPAT
DEPARTMENT OF ANAESTHESIOLOGY, BHAGAT PHOOL SINGH GOVERNMENT MEDICAL COLLEGE KHANPUR KALAN SONIPAT
Sonipat
HARYANA
131305
India 
Phone  9953993573  
Fax    
Email  minkee@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRATEEK 
Designation  Assistant Professor MBBS,MD (ANAESTHESIOLOGY) 
Affiliation  BPS GMC KHANPUR KALAN SONIPAT  
Address  DEPARTMENT OF ANAESTHESIOLOGY, Bhagat Phool Singh Govt Medical CollegeKHANPUR KALAN SONIPAT
DEPARTMENT OF ANAESTHESIOLOGY, Bhagat Phool Singh Govt Medical CollegeKHANPUR KALAN SONIPAT
Sonipat
HARYANA
131305
India 
Phone  9460278499  
Fax    
Email  neopatricks@gmail.com  
 
Source of Monetary or Material Support  
Bhagat PHOOL Singh Government Medical College Khanpur Kalan Sonipat  
 
Primary Sponsor  
Name  Bhagat Phool SINGH Govt Medical College  
Address  DEPARTMENT OF ANAESTHESIOLOGY, Bhagat Phool SINGH Govt Medical College KHANPUR KALAN SONIPAT 
Type of Sponsor  Government medical college 
 
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 
NAVNEET  Bhagat Phool Singh Government Medical College   Main Operation Theater Complex , FIRST floor , Department of Anaesthesia
Sonipat
HARYANA 		 8307008945

dhillonnavneet2222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector Spinae Plane Block  30 ml of 0.25 % ropivacaine will be administered using ultrasound- guided right sided erector spinae plane block unilaterally before surgical incision.  
Intervention  Single puncture subcostal transversus abdominis plane and rectus sheath block.  30 ml of 0.25 % ropivacaine will be administered using ultrasound- guided right sided single puncture subcostal transversus abdominis plane and rectus sheath block before surgical incision. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Quality of recovery after single puncture subcostal transversus abdominis plane and
rectus sheath block versus erector spinae plane block in patients undergoing laparoscopic
cholecystectomy under general anaesthesia. 		 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
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.
2) To compare the perioperative hemodynamic parameters in both the groups.
3) To compare the side effects (nausea, vomiting etc) in both groups. 		 24 hours 
 
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 2/ Phase 3 
Date of First Enrollment (India)   22/12/2025 
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="6"
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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhillonnavneet2222@gmail.com].

  6. For how long will this data be available start date provided 30-05-2028 and end date provided 30-05-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

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