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CTRI Number  CTRI/2025/12/098901 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   studying the effect of nerve block (retrolaminar block) on both sides on reduction in pain intensity in patient operated for laparoscopic guided uterus removal surgery 
Scientific Title of Study   Ultrasound guided bilateral retro laminar block for post operative analgesia in patients undergoing total laproscopic hysterectomy: A randomised controlled 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 Akshat Chaturvedi  
Designation  Junior Resident  
Affiliation  AIIMS, New Delhi  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care Room 5011, 5th floor, Academic Block, AIIMS New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8869985299  
Fax    
Email  jsrhhm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Choudhary  
Designation  Assistant Professor  
Affiliation  AIIMS, New Delhi  
Address  Room number 434, fourth floor, surgery block,AIIMS New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8447698566  
Fax    
Email  drnitinchoudhary@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Nitin Choudhary  
Designation  Assistant Professor  
Affiliation  AIIMS, New Delhi  
Address  Room number 434, fourth floor, surgery block,AIIMS New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8447698566  
Fax    
Email  drnitinchoudhary@yahoo.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  AIIMS, New Delhi  
Address  AIIMS, New Delhi - 110029, India  
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 
Dr Akshat Chaturvedi   AIIMS New Delhi   MCH OT complex, MCH block, AIIMS New Delhi 110029
South
DELHI 		 8869985299

jsrhhm@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: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group   No block will be given and they will also be observed for analgesia requirement for 24 hours postoperatively  
Intervention  Ultrasound guided bilateral retro laminar block  The block will be given 30 minutes before the start of surgery and the patient will be followed for 24 hours in the postoperative period for the analgesic requirement 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA PS I-II, scheduled for total laparoscopic hysterectomy under general anaesthesia. 
 
ExclusionCriteria 
Details  Patient refusal, allergy to local anaesthetic, cardiac/hepatic/renal dysfunction, BMI more than 30 kg per meter square, infection at site of block, coagulopathy, chronic opioid use, altered mental status. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post operative pain score using numerical rating scale ( NRS ) following ultrasound guided bilateral retro laminar block in patients undergoing total laparoscopic hysterectomy ( 0 = no pain , 10 = worst pain imaginable)  1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours postoperatively  
 
Secondary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia.  Whenever NRS score is greater than 4, postoperatively for the first 24 hours. 
Total intra operative opioid requirement.  During the surgery, if heart rate and mean arterial pressure increases more than 20% of baseline values. 
Total requirement of rescue analgesia.  First 24 hours postoperatively. 
To compare post operative recovery using Quality of Recovery-15 ( QoR-15) questionnaire.  At first post operative day after 24 hours of anesthesia.  
Time to ambulation.  0 to 48 hours. 
Complications or side effects  0 to 48 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/01/2026 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - None of the above

  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 [jsrhhm@gmail.com].

  6. For how long will this data be available start date provided 14-07-2027 and end date provided 14-07-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary   Total laparoscopic hysterectomy is widely performed for various benign gynaecological conditions, although minimally invasive, it can result in significant post operative pain. Current pain management practices often rely heavily on opioids, which are associated with adverse effects, regional anaesthesia techniques offer an effective, opioid sparing alternative. The ultrasound guided bilateral retro laminar block has demonstrated promising results in thoracic and upper abdominal surgeries, however, evidence on its efficacy in lower abdominal and pelvic surgeries is sparse. This study aims to address this lacuna in literature. 
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