| CTRI Number |
CTRI/2020/10/028207 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
29/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial comparing , Bupivacaine (local anesthetic )injection on either side of neck of uterus and vaginal stump left behind after total laparoscopic uterus removal versus vaginal stump injection of bupivacaine alone in reducing postoperative pain after total laparoscopic uterus removal. |
|
Scientific Title of Study
|
A randomized controlled trial comparing the efficacy of Bupivacaine injection in vaginal vault and para-cervical region vs vaginal vault infiltration with Bupivacaine after Total Laparoscopic Hysterectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaloni Subramani |
| Designation |
Junior resident |
| Affiliation |
AIIMS , New Delhi |
| Address |
Gynae office , third floor , academic section , AIIMS , New Delhi.
South
DELHI
110029
India |
| Phone |
9500147141 |
| Fax |
|
| Email |
kaloni1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr K K Roy |
| Designation |
Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
3076 , III floor , teaching block , department of obs and gynae , AIIMS , Ansari Nagar , New Delhi .
South
DELHI
110029
India |
| Phone |
9811317011 |
| Fax |
|
| Email |
drkkroy2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaloni Subramani |
| Designation |
Junior resident |
| Affiliation |
AIIMS , New Delhi |
| Address |
Gynae office , third floor , academic section , AIIMS , New Delhi.
DELHI
110029
India |
| Phone |
9500147141 |
| Fax |
|
| Email |
kaloni1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences , Sri aurobindo Marg , Ansari nagar east , New Delhi , 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
All India Institute Of Medical Sciences , Sri aurobindo Marg , Ansari nagar east , New Delhi , 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kaloni Subramani |
All India Institute Of Medical Sciences |
3076 , III floor , teaching block , department of obs and gynae , AIIMS , Ansari Nagar , New Delhi .
South
DELHI |
9500147141
kaloni1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Of AIIMS , New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, (3) ICD-10 Condition: N925||Other specified irregular menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Para cervical block with vault infiltration |
para cervical block with 10 ml of 0.5 % Bupivacaine and vault infiltration with 10 ml of 0.5 % Bupivacaine |
| Intervention |
vault infiltration |
vault infiltration with 10 ml of 0.5 % Bupivacaine. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Benign Gynecological conditions.
2.With or without salpingo oophorectomy.
3.Consenting women
|
|
| ExclusionCriteria |
| Details |
1.Extensive additional tissue manipulation during surgery
2.Undue prolonged surgeries
3.Gynecological malignancies
4.Conversion to laparotomy
5.History of PID
6.Known allergy to amide anesthetics
7.Women not consenting to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale of pain |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual analog scale of pain |
2 hours and 6 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/10/2020 |
| 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)?
Response - NO
|
|
Brief Summary
|
The study is a randomized , double blinded , two armed comparative trial comparing safety and efficacy of two methods - vault infiltration with Bupivacaine versus paracervical block and vault infiltration with Bupivacaine after total laparoscopic hysterectomy . 10 ml of 0.5 % Bupivacaine will be injected in vault to group I and both paracervical and vault infiltration of 10 ml 0.5% Bupivacaine each will be administered to group II after Total laparoscopic hysterectomy done for benign gynaecological conditions and their postoperative pain is measured at 1 , 2 and 6 hours by VAS score from the time of vault infiltration and compared . |