| CTRI Number |
CTRI/2025/09/094278 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief after gallbladder surgery: A study comparing two doses of a medicine dexmedetomidine mixed with ropivacaine sprayed inside the abdomen in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparative Study of Intraperitoneal Instillation
of Ropivacaine with Two Different Doses of Dexmedetomidine for Postoperative Analgesia 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 |
Maneesh V S |
| Designation |
PG Student |
| Affiliation |
Naruvi Hospitals |
| Address |
Collectors Office Road, Bangalore Chennai National Highway NH 48 Vellore 632 004
Vellore
TAMIL NADU
632004
India |
| Phone |
9840958942 |
| Fax |
|
| Email |
vsmaneesh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saravanan Ankichetty |
| Designation |
HOD ,Senior Consultant |
| Affiliation |
Naruvi Hospitals |
| Address |
Collectors Office Road, Bangalore Chennai National Highway NH 48 Vellore 632 004
Vellore
TAMIL NADU
632004
India |
| Phone |
9629957683 |
| Fax |
|
| Email |
sarandoc2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maneesh V S |
| Designation |
PG Student |
| Affiliation |
Naruvi Hospitals |
| Address |
Collectors Office Road, Bangalore Chennai National Highway NH 48 Vellore 632 004
Vellore
TAMIL NADU
632004
India |
| Phone |
9840958942 |
| Fax |
|
| Email |
vsmaneesh99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naruvi Hospitals Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore |
|
|
Primary Sponsor
|
| Name |
Naruvi Hospitals |
| Address |
Naruvi Hospitals Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore
Address
Vellore
TAMIL NADU
632004
India |
| 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 |
| Maneesh V S |
Naruvi Hospitals |
Collectors Office Road Bangalore Chennai National Highway NH 48 Vellore 632004
Vellore
TAMIL NADU |
9840958942
vsmaneesh99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of Naruvi Hospitals, Vellore, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Group RD2: Intraperitoneal spraying of 0.2% Ropivacaine 40ml
with 1.0 µg/kg Dexmedetomidine |
| Intervention |
Dexmedetomidine |
Group RD1: Intraperitoneal spraying of 0.2% Ropivacaine 40ml
with 0.5 µg/kg Dexmedetomidine
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years undergoing elective laparoscopic
cholecystectomy
ASA physical status I,II. |
|
| ExclusionCriteria |
| Details |
ASA physical status III or IV.
Patients with contraindications to ropivacaine or dexmedetomidine.
Patients with chronic pain conditions or on chronic opioid therapy.
Patients who are unwilling to participate in the study. |
|
|
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 |
To evaluate the duration of analgesia following intraperitoneal
administration of ropivacaine with two different doses of
dexmedetomidine. |
Continuous monitoring until first rescue analgesic — records exact time (hours and minutes) from end of surgery to first rescue dose.
Pain scores (NPRS) to detect the need for rescue will be recorded at: 0 h (on arrival to PACU), 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 12 h, 18 h and 24 h.
If no rescue analgesic is required within 24 h, duration is censored at 24 h. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the total analgesic consumption in the first 24 hours
postoperatively.
To evaluate sedation scores at various time intervals.
To evaluate the incidence of shoulder pain in the first 24 hours.
To monitor the postoperative bowel movements |
Total analgesic consumption recorded cumulatively at 24 hours
Ramsay sedation score at 0,1,2,3,4,5,6,12,18,24 hours
Shoulder pain assessed at 1,6,24 hours (present/absent, onset noted)
Bowel movements monitored up to 24 hours (time of first flatus recorded)
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="6"
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 study is a prospective randomized double blind parallel group active controlled trial conducted in patients undergoing elective laparoscopic cholecystectomy. The aim is to compare the efficacy of intraperitoneal ropivacaine combined with two different doses of dexmedetomidine for postoperative analgesia. Patients will be randomly assigned to receive ropivacaine with dexmedetomidine 0.5 microgram per kilogram or ropivacaine with dexmedetomidine 1 microgram per kilogram. The primary outcome is the duration of analgesia measured as time to first rescue analgesic requirement. Secondary outcomes include total analgesic consumption in the first 24 hours, incidence of shoulder pain, sedation scores, and postoperative bowel movements. This study is expected to identify the optimal and safe dose of dexmedetomidine for intraperitoneal use in order to improve postoperative pain relief and reduce opioid related adverse effects. |