| CTRI Number |
CTRI/2024/11/076980 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Pain Management Efficacy in Gallbladder Surgery: Bupivacaine vs. Ropivacaine with Dexmedetomidine |
|
Scientific Title of Study
|
Comparison of Post Operative Analgesic Efficacy of Bupivacaine and Ropivacaine with Dexmedetomidine using Ultrasound Guided Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy under General Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gandharv Singh |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room number 101 Operation Theatre complex 3rd floor, Department of Anaesthesia at Dr Rajendra Prasad Government Medical College Tanda
Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9711723788 |
| Fax |
|
| Email |
gandharvsingh654@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aman Thakur |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room 104, Operation theatre complex 2nd floor Department Of Anaesthesia, DR Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418560804 |
| Fax |
|
| Email |
aman.zander@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gandharv Singh |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
| Address |
Room number 101 Operation Theatre complex 3rd floor, Department of Anaesthesia at Dr Rajendra Prasad Government Medical College Tanda
Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9711723788 |
| Fax |
|
| Email |
gandharvsingh654@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendent Office, Room No. 203, First Floor (Block A), Dr Rajendra Prasad Government Medical College,Tanda, Kangra, Himachal Pradesh, 176001, India |
|
|
Primary Sponsor
|
| Name |
Gandharv Singh |
| Address |
Boys PG Hostel, Dr Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh, 176001, India |
| Type of Sponsor |
Other [self] |
|
|
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 Gandharv Singh |
Dr. Rajendra Prasad Government Medical College |
Operation Theatre Complex, 3rd floor, Department of Anaesthesia, Dr. RPGMC TANDA at KANGRA
Kangra
HIMACHAL PRADESH |
9711723788
gandharvsingh654@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Oblique Subcostal Transverse Abdominis Plane block in Laparoscopic Cholecystectomy under General Anaesthesia |
Patients are randomly selected and Ultrasound Guided Oblique Subcostal Transverse Abdominis Plane Block given after Laparoscopic Cholecystectomy under General Anaesthesia, using Bupivacaine and Ropivacaine, along with dexmedetomidine. Patients are then followed up for 24 hours. Total duration of this study will be 12 months. |
| Comparator Agent |
Ultrasound guided Oblique Subcostal Transverse Abdominis Plane block in Laparoscopic Cholecystectomy under General Anaesthesia |
Ultrasound Guided Oblique Subcostal Transverse Abdominis Plane Block given in Laparoscopic Cholecystectomy under General Anaesthesia with bupivacaine and ropivacaine, along with dexmedetomidine, to know which drug combination is more effective for post operative analgesia. Total duration of study will be 12 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female between Age group 20- 60 years.
ASA I-II
BMI 18.5-29.9.
Patient giving consent |
|
| ExclusionCriteria |
| Details |
Patient’s refusal to participate in the study.
Patients having bleeding disorders.
Hypersensitivity to local anaesthetics and study drugs.
Local infection at the site where needle is to be inserted.
Patients with dysrhythmias, and on beta blockers.
Patients on anticoagulants.
Chronic treatment with Calcium Channel Blockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare Post Operative Analgesic Efficacy of Bupivacaine and Ropivacaine with Dexmedetomidine using Ultrasound Guided Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy under General Anaesthesia |
1 hour, 4 hours, 8 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study total top up analgesic doses requirement in 24 hours post operatively.
2. To study for side effects if any. |
1 hour, 4 hours, 8 hours, 12 hours, 24 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gandharvsingh654@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Using ultrasound guided subcostal transverse abdominis plane block, for post operative pain relief, for patients undergoing laparoscopic cholecystectomy, efficacy of bupivacaine with dexmedetomidine will be compared with ropivacaine with dexmedetomidine, through follow up of patients post operatively, for pain scoring. |