FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/024994 [Registered on: 04/05/2020] Trial Registered Prospectively
Last Modified On: 02/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of post operative pain after Total Lparoscopic Hysterectomy  
Scientific Title of Study   Assessment of Vaginal Vault infiltration by Bupivacaine for postoperative pain after Total Laparoscopic Hysterectomy : ARandomized Control Trial . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KALLOL KUMAR ROY 
Designation  PROFESSOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES Room no 3085 3rd floor Department of Obstetrics and Gynaecology Ansari Nagar New Delhi 110029

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  drkkroy2003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  KALLOL KUMAR ROY 
Designation  PROFESSOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES Room number 3085, third floor Department of Obstetrics and Gynaecology Ansari nagar, New Delhi 110029

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  drkkroy2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  KANIKARAM POOJITHA KALYANI 
Designation  JUNIOR RESIDENT DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCINECES 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES Room number 3085, third floor Department of Obstetrics and Gynaecology Ansari Nagar New Delhi 110029

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  kpooji@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology All India Institute Of Medical Sciences New Delhi  
 
Primary Sponsor  
Name  Department of Obstetrics and Gynaecology 
Address  All India Institute Of Medical Sciences Ansari nagar, New Delhi. 110029 
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 
Kanikaram Poojitha Kalyani  ALL INDIA INSTITUTE OF MEDICAL SCIENCES  All India Institute of medical Sciences room no 3085,third floor Department of Obstetrics and Gynaecology Ansari nagar New Delhi 110029
New Delhi
DELHI 		 9717468813

kpooji@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  No local anaesthetic agent Iis inflitrated after suturing the vault . 
Intervention  ofInfiltration of 0.25% 10ml of Bupivacaine in the vaginal vault  Intervention Group A in which Bupivacaine will be inflitrated laparoscopically after suturing the vault.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. All patients who needs TLH with or without bilateral salpingo-oophorectomy for benign conditions.
2. Uterine size ≤12weeks of pregnancy
 
 
ExclusionCriteria 
Details  1. Presence of malignancy
2. Contraindication to any medication which will be used in the study (Bupivacaine, paracetamol)
3. History of chronic PID
4. History of previous multiple surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of post operative pain and short term morbidity in both the groups.   on post operative day 0.
3hours, 6hours, 8 hours 12 and 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
NONE  NONE 
 
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)   04/05/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

All patients for total laparoscopic hysterectomy( TLH )  for benign condition will be recruited from gynaecology OPD at All India Institute of Medical Sciences, New Delhi.

Study Design: Prospective two arms double blinded Randomized Control Trial.

Total number of patients recruited will be– 60

Patients will be randomly allocated in two groups.

Group I – Intervention group (no. 30) that will receive Bupivacaine infiltration to vaginal vault after TLH.

Group II – Control group (No. 30) that will not receive Bupivacaine infiltration in vaginal vault.

The randomization of participants into their respective group will be allocated using a computer-generated randomization programme. The allocation cards will be sealed in sequentially numbered envelope. The principal surgeon will open the envelopes in the operation theatre prior to surgery.

 
Close