| CTRI Number |
CTRI/2024/07/070018 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| 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
|
This study compares two drugs namely 0.5percent bupivacaine and 0.75 percent ropivacaine with an additive of dexmedetomidine used in transversus abdominis plane block for the duration of postoperative pain relief in patients undergoing lower abdominal surgeries under general anaesthesia |
|
Scientific Title of Study
|
The effectiveness of 0.5 percent isobaric bupivacaine plus Dexmedetomidine Vs 0.75 percent ropivacaine plus dexmedetomidine for postoperative analgesia using ultrasound guided transversus abdominis plane block for abdominal surgeries under general anaesthesia : a randomised control 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 Harshitha Konanki |
| Designation |
Junior Resident |
| Affiliation |
KLE DR Prabhakar Kore Hospital and MRC |
| Address |
Department of anaesthesiology,
Jawaharlal Nehru Medical College,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9626142824 |
| Fax |
|
| Email |
harshithakonanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MG Dhorigol |
| Designation |
Professor |
| Affiliation |
KLE DR Prabhakar Kore Hospital and MRC |
| Address |
Department of anaesthesiology,
Jawaharlal Nehru Medical College,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844778096 |
| Fax |
|
| Email |
mallappadhorigol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MG Dhorigol |
| Designation |
Professor |
| Affiliation |
KLE DR Prabhakar Kore Hospital and MRC |
| Address |
Department of anaesthesiology,
Jawaharlal Nehru Medical College,
Belagavi
KARNATAKA
590010
India |
| Phone |
9844778096 |
| Fax |
|
| Email |
mallappadhorigol@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES DR Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar,Belagavi, Karnataka, India 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Harshitha Konanki |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Nehru nagar,Belagavi, Karnataka, India 590010 |
| 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 Harshitha Konanki |
KLE Dr Prabhakar Kore Hospital and MRC |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Belagavi
Belgaum
KARNATAKA |
9626142824
harshithakonanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5 percent Isobaric Bupivacaine and Dexmedetomidine |
15ml of 0.5 percent Bupivacaine-75mg and 10mcg of dexmedetomidine on each side for Transversus Abdominis Plane Block |
| Comparator Agent |
0.75 percent Ropivacaine and Dexmedetomidine |
15ml of 0.75percent Ropivacaine-150 mg and 10mcg on each side for Transversus Abdominis Plane Block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between ages of 18 and 65 years, ASA grade 1 and 2 undergoing lower abdominal surgeries under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and 4
Hypersensitivity to Local anaesthesia
patients with infection at the site of injection
patients who have coagulopathies
patients on systemic anticoagulant medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of postoperative analgesia after Transversus Abdominis Plane block in patients undergoing abdominal surgeries using 0.5 percent bupivacaine and dexmedetomidine compared with 0.75 percent ropivacaine and dexmedetomidine |
2 hours, 4 hours, 9 hours, 18 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the effect of Transversus Abdominis Plane block on Perioperative hemodynamic status- Heart rate, Non-invasive Blood Pressure, SpO2 |
2 hours, 4 hours, 9 hours, 18 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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 - NO
|
|
Brief Summary
|
Transversus Abdominus Plane block can be used to manage postoperative pain in patients undergoing lower abdominal surgeries under general anesthesia. In this study we are comparing two drugs- 0.5% Bupivacaine and 0.75% Ropivacaine with an adjuvant of dexmedetomidine to analyse the duration of postoperative analgesia provided by the drugs. Perioperative hemodynamic status will also be studied |