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CTRI Number  CTRI/2021/10/037459 [Registered on: 21/10/2021] Trial Registered Prospectively
Last Modified On: 16/07/2024
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   A study to see the effect of local anaesthetic drug to decrease the pain after laparoscopic removal of uterus. 
Scientific Title of Study   Paracervical block for immediate post operative pain prevention after total laparoscopic hysterectomy: A Placebo controlled Randomized trial 
Trial Acronym  PCB-TLH 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumanjot Kaur 
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  room no 3093, 3rd floor, department of obstetrics and gynaecology, academic block, AIIMS jodhpur
room no 3093, 3rd floor, department of obstetrics and gynaecology, academic block, AIIMS jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  8146675980  
Fax    
Email  sumanjot83@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashank Shekhar 
Designation  Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No. 3093, 3rd floor, Department of Obstetrics and Gynaecology, Academics block, AIIMS Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996917  
Fax    
Email  longshanks28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumanjot Kaur 
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  room no 3093 third floor Department of obstetrics and gynaecology Academics block AIIMS Jodhpur
room no 3093 third floor Department of obstetrics and gynaecology Academics block AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India 
Phone  8146675980  
Fax    
Email  sumanjot83@gmail.com  
 
Source of Monetary or Material Support  
D&T complex, 2nd floor,AIIMS Industrial area, Basni, Jodhpur. 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS, Jodhpur 
Type of Sponsor  Research institution and hospital 
 
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 Sumanjot Kaur  AIIMS Jodhpur Department of Obstetrics and Gynecology  Department of Obstetrics and Gynecology
Jodhpur
RAJASTHAN 		 8146675980

sumanjot83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECAIIMSJODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, (2) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Normal Saline   only one dose at time of surgery. 
Intervention  Paracervical block  only one dose at time of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Patients undergoing Laparoscopic Hysterectomy for benign conditions and for
premalignant lesions requiring simple TLH without additional procedures ( like
lymphnode dissection)
2. Patients consenting for the study. 
 
ExclusionCriteria 
Details  1. TLH for Extensive Endometriosis.
2. TLH with Pelvic lymph nodal dissection in cases of Carcinoma Cervix, Carcinoma
Endometrium.
3. Uterus of size 14 weeks or higher.
4. Allergy to Bupivacaine.
5. Patients not giving consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in the VAS Score at 30 minutes and at 60 minutes after TLH in the subjects that received 0.5% Bupivacaine v/s those who
received Placebo. 		 30 minutes and at 60 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of hospital stay  48 hours 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "154"
Final Enrollment numbers achieved (India)="154" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) 31/03/2023 
Date of First Enrollment (Global)  01/11/2021 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [sumanjot83@gmail.com].

  6. For how long will this data be available start date provided 16-07-2024 and end date provided 01-01-2025?
    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 - Mendeley data repository
Brief Summary
Modification(s)  

Our trial found out significant reduction in pain scores after administration of paracervical block for preemptive analgesia.

The postoperative pain scores were significantly lower in the bupivacaine group; VAS at 30 minutes (5.804±1.301 vs. 6.361±1.321, p=0.011); VAS at 60 minutes (6.112±1.268 vs. 6.609±1.272, p=0.019). The time to first mobilization was similar in both the groups (16.77±3.152 vs. 17.26±3.504, p=0.376). The need for additional analgesia was reduced in the group receiving paracervical block with bupivacaine but the difference was not statistically significant (24.3% vs. 28.4%, p=0.576). The duration of hospital stay was similar in both groups (Interquartile range of 2-3 for both the groups, p=0.23).

While the study did not find statistically significant differences in the surrogate markers of postoperative pain such as the need for additional analgesia or duration of hospital stay, the trend toward reduced analgesic requirements in the bupivacaine group is promising.


 
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