| CTRI Number |
CTRI/2025/08/093706 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of dexamethasone with ropivacaine in a regional plane block to provide better pain relief in patients undergoing gall bladder surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Dexamethasone as an adjuvant to 0.25 percent Ropivacaine vs 0.25 percent Ropivacaine with Normal Saline in External Oblique Intercostal Plane Block in patients undergoing Laparoscopic Cholecystectomy |
| 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 Keerthana R |
| Designation |
DNB Resident |
| Affiliation |
Ayushman Hospital and Health Services |
| Address |
Department of Anaesthesiology
Operation Theatre
Third floor
Ayushman Hospital and Health Services
Sector 10
Dwarka
New Delhi
New Delhi
DELHI
110075
India |
| Phone |
9061366174 |
| Fax |
|
| Email |
keerthanar798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Dhir |
| Designation |
HOD and Senior Consultant, Anaesthesia |
| Affiliation |
Ayushman Hospital and Health Services |
| Address |
Department of Anaesthesiology
Operation Theatre
Third floor
Ayushman Hospital and Health Services
Sector 10
Dwarka
New Delhi
New Delhi
DELHI
110075
India |
| Phone |
9899828043 |
| Fax |
|
| Email |
mamsdhir27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kriti Singh |
| Designation |
Senior Consultant, Anaesthesia |
| Affiliation |
Ayushman Hospital and Health Services |
| Address |
Department of Anaesthesiology
Operation Theatre
Third floor
Ayushman Hospital and Health Services
Sector 10
Dwarka
New Delhi
New Delhi
DELHI
110075
India |
| Phone |
9890144118 |
| Fax |
|
| Email |
drkritisingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayushman Hospital and Health Services
Sector 10
Dwarka
New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Keerthana R |
Ayushman Hospital and Health Services |
Department of Anaesthesiology
Operation Theatre
Third floor
Ayushman Hospital and Health services
Sector 10
Dwarka
New Delhi
South West
DELHI |
9061366174
keerthanar798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayushman Hospital and Health Services Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25% Ropivacaine 20cc with Dexamethasone 1ml(4mg) on each side |
Given bilaterally in External Oblique Intercostal Plane Block as a part of multimodal analgesia in Laparoscopic Cholecystectomy patients. Study will be done over a period of one year |
| Comparator Agent |
0.25% Ropivacaine 20cc with Normal Saline (1ml) on each side |
Given bilaterally in External Oblique Intercostal Plane Block as a part of multimodal analgesia in Laparoscopic Cholecystectomy patients. Study will be done over a period of one year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
With ASA physical status classification of I and II
Scheduled to undergo elective laparoscopic cholecystectomy surgery
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Coagulation disorders
Liver or kidney disease
Abdominal surgery history
Infection in the block application area
Chronic opioid use
Local anaesthetic allergy
Pregnancy or BMI less than 18 or more than 35
Diabetes Mellitus
|
|
|
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 |
| 24 hour tramadol consumption in mg |
15,30,60 mins
2,6,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Rating Scale |
15,30,60 mins
2,6,12,24 hours |
| Post Operative Nausea and Vomiting Score |
15,30,60 mins
2,6,12,24 hours |
| Sedation Score |
15,30,60 mins
2,6,12,24 hours |
| Blood glucose levels 6hrs after block |
6 hrs |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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 Yet Recruiting |
| 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
|
Pain following laparoscopic cholecystectomy is a common complaint
that prolongs hospital stay and therefore increases morbidity. Most patients experience mild to moderate pain after laparoscopic cholecystectomy. External oblique intercostal plane block is a novel block, which
has been described as an important modification of the fascial plane blocks
that can consistently involve the upper lateral abdominal walls. Ropivacaine is a long acting local anaesthetic and has a
documented better safety profile than other local anaesthetics. . Dexamethasone is a highly potent, long-acting glucocorticoid with
analgesic, antiemetic, and anti-inflammatory properties, and when used as
an adjuvant in peripheral nerve blocks, increases the duration of analgesia with
minimal side effects and has an added advantage in decreasing postoperative
nausea and vomiting. The proposed study aims
to assess the efficacy of dexamethasone as an adjuvant to ropivacaine in
comparison to plain ropivacaine on External oblique intercostal plane block in patients undergoing laparoscopic cholecystectomy as a part of
multimodal analgesia. We hypothesize that the
addition of dexamethasone 8 mg to ropivacaine 0.25 percent in External oblique intercostal plane block would prolong the
analgesic effect and reduce 24hr tramadol consumption when compared with plain
ropivacaine 0.25 percent in patients undergoing laparoscopic cholecystectomy.
|