| CTRI Number |
CTRI/2025/07/090170 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of intravenous Dexamethasone on postoperative pain relief after ultrasound guided Transversus Abdominis Plane block in adult patient undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Effect of intravenous Dexamethasone on post operative analgesia following Ultrasound guided Transversus Abdominis Plane block in adult patient undergoing laparoscopic cholecystectomy under general anesthesia :Randomised placebo controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Shekhawat |
| Designation |
Post graduate student Anaesthesia |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi |
| Address |
Department of Anaesthesia and ABVIMS and Dr Ram Manohar Lohia Hospital Delhi
New Delhi
DELHI
110001
India |
| Phone |
9667660095 |
| Fax |
|
| Email |
ankitshekhawat507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohandeep Kaur |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi |
| Address |
Department of Anaesthesia ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
986892253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Shekhawat |
| Designation |
Post graduate student Anaesthesia |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi |
| Address |
Department of Anaesthesia and ABVIMS and Dr Ram Manohar Lohia Hospital Delhi
New Delhi
DELHI
110001
India |
| Phone |
966766095 |
| Fax |
|
| Email |
ankitshekhawat507@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi
110001
Delhi
India
|
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr Ram Manohar Lohia Hospital |
| Address |
Baba Kharak Singh Road near Gurudwara Bangla Sahib Dr Ram Manohar Lohia Hospital New Delhi
110001
Delhi
India
|
| 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 Ankita Shekhawat |
ABVIMS and Dr Ram Manohar Lohia Hospital |
Department of Anaesthesia Administrative Block Room Number 301 Baba Kharak Singh Road near Gurudwara Bangla Sahib Dr Ram Manohar Lohia Hospital New Delhi 110001
Delhi
India
New Delhi
DELHI |
9667660095
ankitshekhawat507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS Dr RML Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Patient will be brought to the operation theatre , injection dexamethasone 0.11mg/kg in 2ml (intravenous) will be given to the patient prior to ultrasound guided Transversus Abdominis Plane.After the end of surgery ultrasound guided Transversus Abdominis Plane block will be performed using 20ml of 0.375% ropivacaine .Patient will be assessed for duration of analgesia from 30 minute of arrival to 1hr, 2hr, 3hr, 6hr, 12hr and 24hr. |
| Comparator Agent |
Normal Saline |
Patient will be brought to the operation theatre , normal saline in 2ml (intravenous) will be given to the patient prior to ultrasound guided Transversus Abdominis Plane block.After the end of surgery ultrasound guided Transversus Abdominis Plane block will be performed using 20ml of 0.375% ropivacaine .Patient will be assessed for duration of analgesia from 30 minute of arrival to 1hr, 2hr, 3hr, 6hr, 12hr and 24hr.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II , BMI Between 18-30kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Pre-existing coagulation disorders
2.Local infection at the sites of injection.
3.Any known drug allergies
4.History of diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Rating scoring(NRS) |
NRS scoring will be assessed -
30 min after surgery.
1 hour after surgery.
2 hour after surgery.
3 hour after surgery.
6 hour after surgery.
12 hour after surgery.
24 hour after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic parameters (Pulse Rate, Systolic Blood Pressure ,Diastolic Blood Pressure and Mean Arterial Pressure)
2. Post Operative Nausea and Vomiting(PONV) scoring. |
Time will be assessed -
30 min after surgery.
1 hour after surgery.
2 hour after surgery.
3 hour after surgery.
6 hour after surgery.
12 hour after surgery.
24 hour after surgery. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
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
|
This is a randomized placebo-controlled study investigating the effect of intravenous dexamethasone on postoperative analgesia in adult patients undergoing laparoscopic cholecystectomy under general anaesthesia. The study includes two groups (54 patients each), In Group A receives IV dexamethasone along with an ultrasound-guided Transversus Abdominis Plane block using 0.375% ropivacaine and in Group B receives normal saline instead of dexamethasone but the same ultrasound-guided Transversus Abdominis Plane block with 0.375% ropivacaine. The primary outcome is to assess the effect of dexamethasone on postoperative analgesia, measured using the Numerical Rating Scale (NRS) at specific time intervals.The secondary outcomes include evaluating the hemodynamic response and Postoperative Nausea and vomiting (PONV) scores at predetermined time points. |