| CTRI Number |
CTRI/2025/04/086052 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing how well different types of numbing medicines work for pain relief after lower belly surgery. We looked at plain Bupivacaine, Bupivacaine mixed with Dexmedetomidine, and Bupivacaine mixed with Clonidine, all given through an ultrasound-guided nerve block. |
|
Scientific Title of Study
|
Comparison of efficacy of plain bupivacaine versus bupivacaine with
dexmedetomidine versus bupivacaine with clonidine in Ultrasound Guided
transversus abdominis Plane Block for duration of postoperative analgesia in patients
undergoing lower abdominal surgeries A double blind randomized controlled 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 |
Raghulpandi |
| Designation |
Postgraduate junior resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of anaesthesiology,AIIMSRaipur
Raipur
Chhattisgarh 492099
India
Department of anaesthesiology,AIIMSRaipur
Raipur
Chhattisgarh 492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
9952623334 |
| Fax |
|
| Email |
Pandiraghul557@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rampal Singh |
| Designation |
Additional Professor, Department of Anesthesiology and Critical Care, AIIMS Raipur. |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of anaesthesiology,AIIMSRaipur
Raipur
Chhattisgarh 492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
9027335921 |
| Fax |
|
| Email |
drrampalsingh@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rampal Singh |
| Designation |
Additional Professor, Department of Anesthesiology and Critical Care, AIIMS Raipur. |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of anaesthesiology,AIIMSRaipur
Raipur
Chhattisgarh 492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
9027335921 |
| Fax |
|
| Email |
drrampalsingh@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| AII INDIA INSTITUTE OF MEDICAL SCIENCE RAIPUR CHHATTISGARH, GE ROAD ,TATIBANDH, PINCODE: 492099 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Raghulpandi |
AIIMS RAIPUR |
Department of anaesthesiology,AIIMS Raipur
Chhattisgarh
492099
India
Raipur
CHHATTISGARH |
9952623334
Pandiraghul557@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine with clonidine |
0.25% of bupivacaine plus clonidine 1 micrograms/kg bilaterally TAP block given post surgery |
| Comparator Agent |
Bupivacaine with dexmeditomidine |
0.25% of bupivacaine plus 0.5 micrograms/kg dexmeditomidine bilaterally TAP block given post surgery |
| Intervention |
Plain bupivacaine |
0.25% plain bupivacaine TAP block bilateral given post surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I or II.
2.Patients undergoing lower
abdominal surgeries.
3.Patients undergoing surgery under spinal |
|
| ExclusionCriteria |
|
|
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 |
Primary objective: Comparison of efficacy of plain Bupivacaine versus Bupivacaine
with Dexmedetomidine versus Bupivacaine with Clonidine in Ultrasound Guided
Transversus Abdominis Plane Block for duration of postoperative analgesia in patients
undergoing lower abdominal surgeries. |
Before giving block and after giving block 0 hour, 2hour, 4th hour, 6th hour
8 th hour, 12 th hour,16 th hour, 20th hour and 24 th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Side effects of the administered drugs.
2. Sedation (using modified Ramsay sedation score) |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 |
|
Date of First Enrollment (India)
|
07/05/2025 |
| 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 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
|
This study evaluates the efficacy of Transversus Abdominis Plane (TAP) block with different adjuvants for postoperative pain relief in lower abdominal surgeries.
• Participants: Patients undergoing surgery, recruited after consent.
• Randomization: Patients are divided into 3 groups (36 each):
• Group B: 0.25% bupivacaine (20 ml/side).
• Group BC: 0.25% bupivacaine + clonidine (1 µg/kg, 20 ml/side).
• Group BD: 0.25% bupivacaine + dexmedetomidine (0.5 µg/kg, 20 ml/side).
• Procedure: TAP block performed under ultrasound guidance. Vitals, pain (NRS), and sedation (Ramsay score) monitored at intervals for 24 hours. Rescue analgesics (paracetamol or diclofenac) will be administered as needed.
• Outcomes:
• Primary: Duration of analgesia (time to significant pain).
• Secondary: Rescue analgesic consumption and side effects.
• Sample Size: 108 patients (36 per group) based on prior studies and statistical power.
This study compares bupivacaine alone and in combination with clonidine or dexmedetomidine for prolonged and effective pain relief. |