| CTRI Number |
CTRI/2025/08/093918 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of USG guided Continuous Paravertebral block vs Continuous Thoracic epidural anaesthesia for postoperative pain management in renal transplant recepient patient and to compare the post operative pain by NRS grading 48 hours post surgery. |
|
Scientific Title of Study
|
Ultrasound guided continuous paravertebral versus thoracic epidural anaesthesia for postoperative pain relief in renal transplant recipients. A randomized controlled trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Rijal |
| Designation |
Junior resident |
| Affiliation |
Post Graduated Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, Nehru Hospital, fourth floor, PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6284188568 |
| Fax |
|
| Email |
praveenrijal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduated Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia , Nehru Hospital , Fourth Floor , PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8699076561 |
| Fax |
|
| Email |
amitkalayat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Rijal |
| Designation |
Junior resident |
| Affiliation |
Post Graduated Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia , Nehru Hospital , Fourth Floor, PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6284188568 |
| Fax |
|
| Email |
praveenrijal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Grant from Department Of Anaesthesia , Fourth Floor , Nehru Hospital , PGIMER , Chandigarh , 160012 , India |
|
|
Primary Sponsor
|
| Name |
Dr Praveen Rijal |
| Address |
Department of Anaesthesia , Fourth floor , Nehru Hospital , PGIMER , Sector 12 , Chandigarh |
| 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 Praveen Rijal |
Post Graduate Institute of Medical Education and Research |
Department Of Anaesthesia , Fourth Floor, A Block ,Sector 12 , Chandigarh
Chandigarh
CHANDIGARH |
06284188568
praveenrijal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute Of Medical Education and Research , Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided Continuous Paravertebral Vs Thoracic Epidural Anaesthesia For Postoperative Pain Relief In Renal Transplant Recepients: Randomized Control Trial |
Intervention group patients will receive ultrasound guided paravertebral space catheter placement under local infiltration anaesthesia. The patient will be placed in the sitting position and an ultrasound high-frequency linear probe will be used to scan at approximately 2–2.5 cm next to T10-T12 spinous process in the median sagittal position. The transverse process, pleura, and thoracic paravertebral space could be clearly visualized under the ultrasound.
A 20 G epidural catheter will threaded 5 cm in cephalad direction. Correct placement of the catheters will be confirmed by USG. Local anaesthetic (Lignocaine 60mg) test dose with mixture of adrenaline (15mcg) will be injected into the epidural catheter to rule out intrathecal and intravascular placement.
|
| Comparator Agent |
Ultrasound Guided Continuous Paravertebral Vs Thoracic Epidural Anaesthesia For Postoperative Pain Relief In Renal Transplant Recepients: Randomized Control Trial |
The comparator Group A patients will receive ultrasound guided epidural catheter placement in Paramedian sagittal oblique method with 18G Tuohy needle at the level of T10-L2 under local anaesthesia using loss of resistance to saline technique. 20G epidural catheter will be inserted upto 4-5 cms into the epidural space towards the cephalad direction. Local anaesthetic (Lignocaine 60mg) test dose with mixture of adrenaline (15mcg) will be injected into the epidural catheter to rule out intrathecal and intravascular placement and continuous infusion 0.125 percent of bupivacaine 48 hours post surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing kidney transplant surgery (living donor and cadaveric) aged 18-65years. |
|
| ExclusionCriteria |
| Details |
Refusal of consent.
Patients with coagulation disorders.
Opioid addiction.
Allergy to local anaesthetics ( Bupivacaine).
Substance addiction or known psychiatric or mental problems.
Local infection of the skin where block is to be given.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect (NRS) at rest of USG guided Paravertebral Block vs Thoracic Epidural Anaesthesia at six hour post surgery. |
Dynamic NRS at 6 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare total opioid(Tramadol) consumption. |
During 48 hours post surgery |
| Dynamic NRS on cough |
at 0,2, 4 , 6 , 12, 24, 48-hour post surgery. |
| To compare the complication such as post operative nausea & vomiting requiring rescue anti emetics , pruritis , hypotension , respiratory depression. |
During 48 hours post surgery. |
| To compare the procedure success rate, total procedure time, needle visibility, first-pass success rate, first-attempt success rate. |
During 48 hours post surgery . |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="3"
Days="5" |
|
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
|
After selection of patients and randomization, patients will be divided into 2 groups, group A and group B. Group A will be USG guided continuous thoracic epidural anaesthesia and Group B will be USG guided continuous Paravertebral block using 0.125 percent bupivacaine 48 hours post surgery. They will be evaluated with total opiod consumption, dynamic NRS for pain. |