| CTRI Number |
CTRI/2022/03/041170 [Registered on: 17/03/2022] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain management in patients undergoing renal stone surgery. |
|
Scientific Title of Study
|
Analgesic effect of ultrasound (USG) guided erector spinae plane block (ESPB) in adult patients undergoing percutaneous nephrolithotomy (PCNL) surgery: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Babbar |
| Designation |
Junior resident |
| Affiliation |
AIIMS Patna |
| Address |
Room number 505, OT complex, 5th floor,
B block, Aiims, patna
Patna
BIHAR
Room number 505, OT complex, 5th floor,
B block, Aiims, patna
Patna
BIHAR
Patna
BIHAR
801507
India |
| Phone |
9646261177 |
| Fax |
|
| Email |
drbabbarprashant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam kumari |
| Designation |
Assistant professor, Department of anaesthesiology |
| Affiliation |
AIIMS Patna |
| Address |
Room number 505, OT complex, 5th floor,
B block, Aiims patna
Patna
BIHAR
Room number 505, OT complex, 5th floor,
B block, Aiims patna
Patna
BIHAR
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam kumari |
| Designation |
Assistant professor, Department of anaesthesia |
| Affiliation |
AIIMS Patna |
| Address |
Room number 505, OT complex, 5th floor,
B block, Aiims, patna
Patna
BIHAR
Room number 505, OT complex, 5th floor,
B block, Aiims, patna
Patna
BIHAR
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Patna, phulwarisharif |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Phulwarisharif Patna, bihar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prashant babbar |
AIIMS Patna |
Operating room no 3, 5th floor, B block, OT Complex
Patna
BIHAR |
9646261177
drbabbarprashant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
IV Patient controlled analgesia |
Intravenous fentanyl is given as 0.5mcg per kg bolus dose with lockout interval of 15 minutes with maximum 4 doses per hour |
| Intervention |
Ultrasound guided Erector spine plane block (ESPB) |
Ultrasound guided ESPB by injecting mixture of 20ml of 0.25% of bupivacaine with 25mcg dexmedetomidine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age (either Sex)18 to70 years
ASA I/II
BMI < 35 mg/m2(80%)
Single-access PCNL. |
|
| ExclusionCriteria |
| Details |
ASA III / IV
Patient’s refusal
Bleeding disorders
A singleton kidney
Infection of the skin at the injecting spot
Patient taking antidepressant, corticosteroid, pain medication, or anticonvulsant.
Allergy to local anesthetic, opioid, and dexmedetomidine.
A mental state that makes it virtually impossible to use an intravenous patient-controlled analgesia (PCA) device appropriately. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative total fentanyl consumptions |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time of first rescue analgesia
2) NRS score postoperative period
3) Worst NRS score
4) Adverse effect
5)Satisfaction score |
NRS score postoperative period at 30 min, 2hour, 4 hour, 8 hour, 12 hour, 24 hour.
Satisfaction score - 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/03/2022 |
| 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
|
This study is designed to know analgesic effect of USG guided Erector spine plane block (ESPB) in patients undergoing Percutaneous nephrolithotomy surgery. USG guided Erector spinae plane block (ESPB) will be given by injecting mixture of 20 ml of 0.25 percent bupivacaine and 25 mcg of dexmedetomidine. This block may be effective in reducing the total analgesic requirements in a patient undergoing percutaneous nephrolithotomy (PCNL) surgery. |