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CTRI Number  CTRI/2025/07/091012 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
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   Effect of introducing low-concentration bupivacaine into the abdominal cavity of participants for post-operative pain relief outcome after laparoscopic hysterectomy. 
Scientific Title of Study   Effect of intra-peritoneal instillation of low-concentration bupivacaine for post-operative analgesia after laparoscopic hysterectomy. 
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 Dishaben Italiya 
Designation  Second Year Resident Doctor 
Affiliation  B.J.Medical College and Civil Hospital 
Address  F3 First Floor Department Of Anaesthesia Civil Hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  9512677974  
Fax  NIL  
Email  italiyadisha2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Solanki 
Designation  Associate Professor 
Affiliation  B.J.Medical College and Civil Hospital  
Address  F3 First Floor Department Of Anaesthesia Civil Hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  9998991716  
Fax  NIL  
Email  nmscbaps@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nilesh Solanki 
Designation  Associate Professor 
Affiliation  B.J.Medical college and Civil Hospital  
Address  F3 First Floor Department Of Anaesthesia Civil Hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  9998991716  
Fax  NIL  
Email  nmscbaps@gmail.com  
 
Source of Monetary or Material Support  
Government of Gujarat Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
 
Primary Sponsor  
Name  Government of Gujarat 
Address  Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat 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 DISHABEN ITALIYA  1200 bed Civil Hospital   D1 First Floor Gynaecology Operation Theatre
Ahmadabad
GUJARAT 		 9512677974
-
italiyadisha2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee B.J. medical college and civil hospital Ahmedabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inta-peritoneal instillation of 100ml normal saline over 10 minutes  Intra-peritoneal instillation of 100ml normal saline at the end of surgery through umbilical port over 10 minutes 
Intervention  Intra-peritoneal instillation of low-concentration bupivacaine over 10 minutes  At the end of laparoscopic hysterectomy Intra-peritoneal instillation of inj.Bupivacaine 0.1% 100ml at the operative site through umbilical port over 10 minutes 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA grade I and II, Elective surgeries 
 
ExclusionCriteria 
Details  Hypersensitivity to local anaesthetics, History of any previous surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare duration of analgesia  Postoperative 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor and compare the incidence of adverse effects  Postoperative 24 hours 
To assess postoperative hemodynamic parameters in both groups  Postoperative 24 hours 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/08/2025 
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="0"
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [italiyadisha2@gmail.com].

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post operative pain management remains a clinical challenge following laparoscopic hysterectomy. Local anaesthetics offer a potential solution for improving pain control while minimizing systemic side effects. Bupivacaine is a long acting anaesthetic known for its efficacy in providing prolonged analgesia. This study is based on the hypothesis that intra peritoneal instillation of low concentration bupivacaine may result in significant postoperative pain relief. 
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