| CTRI Number |
CTRI/2024/09/073926 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of analgesic efficacy of Dexmedetomidine with Bupivacaine v/s Bupivacaine alone in pecto-intercostal fascial plane block in adult patient undergoing median sternotomy: A randomized control trial.The Participants analgesic effect are compare between intervention group and control |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Dexmedetomidine with Bupivacaine v/s Bupivacaine alone in pecto-intercostal fascial plane block in adult patient undergoing median sternotomy: A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Kant AIIMS |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashi Kant |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Patna |
| Address |
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
Patna
BIHAR
800025
India |
| Phone |
09934221343 |
| Fax |
|
| Email |
dr.shashikant2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashi Kant |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Patna |
| Address |
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
Patna
BIHAR
800025
India |
| Phone |
09934221343 |
| Fax |
|
| Email |
dr.shashikant2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashi Kant |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Patna |
| Address |
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
Patna
BIHAR
800025
India |
| Phone |
09934221343 |
| Fax |
|
| Email |
dr.shashikant2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, Patna, Bihar, India, Pin Code 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
All India Institute of Medical Science, Patna, Bihar, India, Pin Code 801507 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shashi Kant |
AIIMS PATNA |
FLAIT NO.101,ANMOL NIDHI REGENCY, ASHIYANA NAGER PHASE 2
Patna
BIHAR |
09934221343
dr.shashikant2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
addition of dexmedetomidine to bupivacaine in pectointercostal interfascial plane block effectively prolong the analgesia for post sternotomy pain and reduce the perioperative opioid consumption after open heart surgery |
addition of dexmedetomidine to bupivacaine in pectointercostal interfascial plane block effectively prolong the analgesia for post sternotomy pain and reduce the perioperative opioid consumption after open heart surgery |
| Intervention |
The aim of this study is to evaluate and compare the analgesic efficacy of dexmedetomidine as an adjuvant to bupivacaine in pectointercostal interfascial plane block in reducing the perioperative (24hrs) opioid consumption in patient undergoing median sternotomy for elective open-heart surgery |
The aim of this study is to evaluate and compare the analgesic efficacy of dexmedetomidine as an adjuvant to bupivacaine in pectointercostal interfascial plane block in reducing the perioperative (24hrs) opioid consumption in patient undergoing median sternotomy for elective open-heart surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1. ASA physical status: I - III
2. Age: 18-70 years
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study
2. Duration of surgery more than 5 hours
3. Hypersensitivity, or a history of Local Anesthetic allergies
4. Undergone emergent or redo surgeries
5. Cognitive dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measure the time to first rescue analgesia post-operative in either of groups. |
measure the time to first rescue analgesia post-operative in either of groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total opioid consumption in 24 hours
2) Time to extubation
3) NRS score post extubation at 1 hour, 3 hours, 6 hours, 12 hours, 24 hours.
4) Adverse effect of block
5) Patient Satisfaction score -24 hour, 48hour
|
1) Total opioid consumption in 24 hours
2) Time to extubation
3) NRS score post extubation at 1 hour, 3 hours, 6 hours, 12 hours, 24 hours.
4) Adverse effect of block
5) Patient Satisfaction score -24 hour, 48hour
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Comparison of analgesic efficacy of Dexmedetomidine with Bupivacaine v/s Bupivacaine alone in pecto-intercostal fascial plane block in adult patient undergoing median sternotomy: A randomized control trial- |