| CTRI Number |
CTRI/2024/03/063870 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/09/2024 |
| 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
|
comparison of effect of Intraperitoneal injection of Dexmedetomidine
or Fentanyl in addition to Ropivacaine for
postoperative pain management after Laparoscopic
Cholecystectomy |
|
Scientific Title of Study
|
Effects of intraperitoneal instillation of Dexmedetomidine
versus Fentanyl as adjuvants to Ropivacaine for
postoperative pain management after 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 Ranjana Bhadauria |
| Designation |
Junior Resident |
| Affiliation |
Hind Institue Of Medical Sciences |
| Address |
Room no 413 Hind private ward Hind Institute of medical sciences Ataria
Hind Institute Of Medical Sciences Ataria Sitapur
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
9458237267 |
| Fax |
|
| Email |
rbhadauria14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Rai |
| Designation |
Professor |
| Affiliation |
Hind Institute of Medical Sciences |
| Address |
Department of Anesthesia
Hind Institute of Medical Sciences Ataria Sitapur
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
8840007687 |
| Fax |
|
| Email |
Sudhir.rai17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana Bhadauria |
| Designation |
Junior Resident |
| Affiliation |
Hind Institute of Medical Sciences |
| Address |
Department Of Anesthesia
Hind Institute of Medical Sciences Ataria Sitapur
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
9458237267 |
| Fax |
|
| Email |
rbhadauria14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hind Institute Of Medical Sciences Mau Ataria Sitapur |
|
|
Primary Sponsor
|
| Name |
Hind Institute of Medical Sciences |
| Address |
Hind Institute of Medical Sciences Mau Ataria Sitapur |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranjana bhadauria |
Hind Institute of Medical Sciences |
Department of Anaesthesia Hind Institute of Medical Sciences Mau, Ataria, Sitapur, U.P
261303
Sitapur
UTTAR PRADESH |
9458237267
rbhadauria14@gmail.com |
| DR Sudhir Kumar Rai |
Hind Institute of Medical Sciences |
Department of Anaesthesia Hind Institute of Medical Sciences Mau, Ataria, Sitapur, U.P
Sitapur
UTTAR PRADESH |
8840007687
sudhir.rai17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC-HIMSA |
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 |
Fentanyl and Dexmeditomidine |
Group Rf- 40 ml of 0.375% ropivacaine + 2 ml fentanyl 1 microgram/kg
Group Rd- 40 ml of 0.375% ropivacaine + 2 ml dexmedetomidine 1 microgram / kg 15 mins before closure of wound through laparoscopic ports |
| Intervention |
Intraperitoneal Instilation Of Ropivacaine with either fentanyl or dexmeditomidine |
Intraperitoneal Instilation Of Ropivacaine with either fentanyl or dexmeditomidine for postoperative pain relief within 24 hrs duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Posted For Elective Laparoscopic Cholecystectomy Of ASA I AND ASA II
2.Patients Of Age 18-60 Years Of Either Sex |
|
| ExclusionCriteria |
| Details |
Pregnancy
Patients With Cardiac/Renal/Psychiatric/Coagulation Disorder
Patient Refusal To Give Consent
Laproscopic Converted To Open Cholecystectomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time duration of first rescue analgesia
|
within 24 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect on NRS in post-operative duration.
Effects on post-operative
hemodynamic stability.
Adverse effects,if any
|
every 1 hr till 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Laparoscopic cholecystectomy (LC) is the most accepted surgical technique for cholelithiasis as compared to open cholecystectomy. Although laparoscopic cholecystectomy (LC) results in less pain than open chole-cystectomy, it is not a pain-free procedure.Multimodal analgesia including parenteral opioids, nonsteroidal anti-inflammatory drugs (NSAID) or local infiltration with local anesthetics is used to reduce pain. Despite their efficacy, all parenteral medications have associated adverse effectsIntraperitoneal injections of local anaesthetic have been proposed to minimize postoperative pain after laparoscopic surgeries. Adjuvants are often added to local anaesthetics for nerve blocks to prolong its anaesthetic effects. Alpha 2 agonists such as clonidine or dexmedetomidine and opioids like fentanyl combined with Bupivacaine has shown to increase the duration of anaesthesia significantly.Ropivacaine newer analgesic, with better toxicity profile compared with other local anaesthetic, such as Bupivacaine, is considered the safest, long acting local anaesthetic available in market.Since there are a few studies which have compared the nociceptive effects of intraperitoneal fentanyl to intraperitoneal dexmedetomidine, Hence the present study was undertaken to compare the effects of intraperitoneal bupivacaine with dexmedetomidine or fentanyl as adjuvants, in patients undergoing ambulatory laparoscopic cholecystectomy |