| CTRI Number |
CTRI/2024/11/076936 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of dexamethasone and midazolam as adjuvant in TAP block on post-op analgesia after laparoscopic surgeries |
|
Scientific Title of Study
|
Comparative study of Dexamethasone and Midazolam as adjuvants to Ropivacaine in Transversus abdominis plane block on post operative analgesia after Laparoscopic lower abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vaibhav kumar |
| Designation |
PG student |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of anesthesiology, sirsunderlal hospital, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
vaibhavkumar166@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. SK Mathur |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, SIRSUNDERLAL HOSPITAL, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
|
| Email |
skmathurbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. SK Mathur |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
1st floor, DEPARTMENT OF ANESTHESIOLOGY, SIR SUNDERLAL HOSPITAL, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
|
| Email |
skmathurbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st floor, Sir Sunderlal Hospital, Institute Medical Sceinces, BHU, Varanasi, Uttar Pradesh, India 221005 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Sir Sunderlal Hospital Institute of Medical Sciences BHU |
| Address |
1st floor Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India 221005 |
| 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 Vaibhav Kumar |
Sir sunderlal hospital, IMS, BHU |
1st floor Departmrnt of Anesthesiology, IMS, BHU
Varanasi
UTTAR PRADESH |
8004464492
vaibhavkumar166@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
USG guided TAP block given with 4mg dexamethasone and 20ml of 0.2% Ropivacaine on both sides post-operatively |
| Intervention |
Midazolam |
USG guided TAP block given with 2mg preservative free midazolam and 20ml of 0.2% Ropivacaine on both sides post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing Laparoscopic lower abdominal surgeries.
2. ASA 1 or 2 physical status. |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent.
2. Local site infection.
3. Any contraindication to peripheral nerve block.
4. Morbid obese (BMI more than or equal to 40kg/m2)
5. Dropout ( Laparoscopic surgeries converted into open 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 |
1. Time duration when first rescue analgesia was needed
2. Total dose of rescue analgesia |
Immediately after shifting to post-op, 1 Hour, 2 Hour, 4 Hour, 6 Hour, 8 Hour, 12 Hour, 16 Hour, 20 Hour, 24 Hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic variability, post-op nausea and vomiting and sedation. |
within 24 hours post operatively. |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| 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="11"
Days="10" |
|
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 - NO
|
|
Brief Summary
|
A double-blind prospective randomised comparative
study will be conducted on 60 patients scheduled for laparoscopic lower abdominal
surgeries. Patients will be randomly allocated using
computer generated random number to be treated with either dexamethasone (Group
D) or preservative free midazolam (Group M). After completion of surgery ultrasound guided TAP
block will be performed in patients of both the groups. Patients in Group D will
receive 0.2% ropivacaine (20 ml) and 2ml normal saline containing 4mg
dexamethasone whereas patients in Group M will receive 0.2% ropivacaine (20 ml)
and 2ml normal saline containing 2 mg of preservative free midazolam. Patients will be shifted to post anaesthesia
care unit (PACU) where post-op monitoring of pain (by VAS score), sedation (by Ramsay
sedation scale), postoperative nausea and/or vomiting (0: no nausea; 1: nausea
no vomiting; and 2: nausea and vomiting), and complications (like pruritus,
headache, local anaesthetic systemic toxicity) will be done till 24h after
surgery |