| CTRI Number |
CTRI/2021/01/030424 [Registered on: 13/01/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between abdominal Irrigation with two different fluids in Reducing Post-Operative Pain in Operative Laparoscopy |
|
Scientific Title of Study
|
Comparison Between Intraperitoneal Irrigation with Sodium Bicarbonate versus Normal Saline in Reducing Post-Operative Pain in Operative Laparoscopy: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Agarwal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
South
DELHI
110023
India |
| Phone |
9636246377 |
| Fax |
|
| Email |
drankita2603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF K K ROY |
| Designation |
PROFESSOR AND UNIT HEAD |
| Affiliation |
AIIMS |
| Address |
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
South
DELHI
110023
India |
| Phone |
9636246377 |
| Fax |
|
| Email |
drkkroy2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Agarwal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
South
DELHI
110023
India |
| Phone |
9636246377 |
| Fax |
|
| Email |
drankita2603@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ankita Agarwal |
AIIMS, New Delhi |
Department of Obstetrics and Genecology office,3rd Floor, AIIMS, Ansari Nagar East, New Delhi 110023
South
DELHI |
9636246377
drankita2603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraperitoneal irrigation with 1 L Normal Saline |
Intraperitoneal irrigation with 1 L normal saline will be done at the end of procedure and will be aspirated back. |
| Intervention |
Intraperitoneal irrigation with Sodium Bicarbonate |
Intraperitoneal Irrigation with 50 ml of 7.5% Sodium Bicarbonate diluted in 1 L normal saline will be done at the end of the procedure and will be aspirated back. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Women requiring level 1 and level 2 operative laparoscopic procedure (ovarian cystectomy, oophorectomy, ovarian drilling, salpingectomy and adhesiolysis).
2. Women consenting to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. History of chronic use of opioids, NSAIDS, alcohol and steroids.
2. Patient with chronic kidney disease, diarrhea, renal tubular acidosis, COPD.
3. Any known allergy to bicarbonate products.
|
|
|
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 |
| Comparison between Post operative pain in intervention and control group |
At 2, 4, 12, 24 hours and 1 week after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in post operative morbidity, hospital stay and early recovery. |
At 2, 4, 12, 24 hours and 1 week after the procedure |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/01/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1)This study is designed to see the postoperative pain at regular interval in gynecological laparoscopic surgeries.2)To compare the efficacy of intraperitoneal sodium bicarbonate with normal saline in reducing post-operative pain in operative laparoscopy
|