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CTRI Number  CTRI/2025/12/099837 [Registered on: 26/12/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Cluster Randomized Trial 
Public Title of Study   A comparison of outcomes between Opioid based Vs Non-Opioid based (Subarachnoid blockade) in General Anesthesia in participants posted for Laparoscopic Hysterectomy by QoR 15 Assessment 
Scientific Title of Study   A comparison of Opioid based Vs Non-Opioid based (Subarachnoid blockade) in General Anesthesia for Laparoscopic Hysterectomy: QoR 15 Assessment 
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 PRIYA CHAVRE 
Designation  ASSISTANT PROFESSOR 
Affiliation  PCMC PGI YCM HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA, DHANVANTARI OT, FIRST FLOOR, PCMC PGI YCM HOSPITAL, PIMPRI, PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9405425407  
Fax    
Email  priyachavre93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PRIYA CHAVRE 
Designation  ASSISTANT PROFESSOR 
Affiliation  PCMC PGI YCM HOSPITAL 
Address  DAPARTMENT OF ANAESTHESIA DHANVANTARI OT, FIRST FLOOR, PCMC PGI YCM HOSPITAL, PIMPRI, PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9405425407  
Fax    
Email  priyachavre93@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRIYA CHAVRE 
Designation  ASSISTANT PROFESSOR 
Affiliation  PCMC PGI YCM HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA DHANVANTARI OT , FIRST FLOOR PCMC PGI YCM HOSPITAL, PIMPRI, PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9405425407  
Fax    
Email  priyachavre93@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  PCMC PGI YCM HOSPITAL 
Address  PCMC PGI YCM HOSPITAL PIMPRI PUNE  
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 PRIYA CHAVRE  PCMC PGI YCM HOSPITAL  DEPARTMENT OF ANAESTHESIA, DHANVANTARI OT , FIRST FLOOR
Pune
MAHARASHTRA 		 9405425407

priyachavre93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTE, PCMCS PGI YCM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  General Anaesthesia  General Anesthesia will be standardized across both groups with premedications and neuromusclcular agent Vecuronium Inhalational agent Isoflurane and maintenance on oxygen and Nitrous oxide at 50%. The patient will be reversed at the end of the procedure wuth neostigmine and glycopyrrolate. 
Comparator Agent  Spinal Anaesthesia  Spinal Anaesthesia will be given in one group at L3-L4 interspace using 2.6cc of Isobaric 0.5% Bupivacaine. In another group only General Anaesthesia will be given. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  ASA I and II females scheduled for laparoscopic hysterectomy 
 
ExclusionCriteria 
Details  ASA III and IV
Patients posted for revision or complicated surgery
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effects of Non opioid based spinal General Anesthesia versus Opioid based General Anesthesia on the QoR-15 in patients undergoing laparoscopic hysterectomy.
 		 At baseline, after 1 hour , 12 hours and 24 hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamic parameters in both groups  At baseline, at post spinal, post intubation, at pneumoperitonuem insufflation, during surgery at 5,30,60,90,120 & 150 minuttes interval. 
To assess consumption of inhalational agent in both the groups  Intraoperatively 
To assess time of regression & time of first rescue analgesia in both the groups  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   05/01/2026 
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="0"
Months="6"
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 - 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

  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 [priyachavre93@gmail.com].

  6. For how long will this data be available start date provided 15-11-2025 and end date provided 15-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Patients undergoing Laparoscopic Hysterectomy will be assigned into two groups randomly after CTRI and IEC approval.

To study and compare QoR-15 scores between Non-Opioid based Spinal General Anaesthesia  and Opioid based General Anaesthesia  in patients undergoing Elective Laparoscopic Hysterectomy

Preoperatively Age Weight Height ASA I OR  II BMI QOR-15 will be recorded Parameters Prior To Induction  Heart Rate  Systolic  And Diastolic Blood Pressure  Mean Arterial Pressure  And Saturation Spo2 will be taken. In one group Patients will be given spinal anesthesia in sitting position and after achieving T4 level they will be given General Anesthesia. In other group patients will be given General Anesthesia with Injection Fentanyl. Intraoperatively following parameters will be monitored Heart rate Systolic blood pressure Diastolic blood pressure Mean arterial pressure Oxygen Saturation MAC ETCO2 at post spinal post intubation at pneumoperitoneum insufflation during surgical manipulation at 5 30 60 90 120 150 min intervals at desufflation at extubation and recovery. QOR-15 will be assessed at baseline and postoperatively at 1hr 12hrs  24hrs interval after the surgery

 
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