| CTRI Number |
CTRI/2019/04/018477 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
23/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of erector spinae plane block in relieving the post operative pain of patients undergoing percutaneous nephrolithotomy |
|
Scientific Title of Study
|
Effectiveness of erector spinae block for pain relief in patients going to have surgery for kidney stones |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arush Singla |
| Designation |
Post graduate Junior resident |
| Affiliation |
Government Medical College Hospital, Chandigarh |
| Address |
Department of anaesthesia and intensive care, GMCH 32, Sector 32, Chandigarh
Singla Nursing Home, ward no. 10, zora basti, Jakhal road, Patran, Punjab.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7009947996 |
| Fax |
|
| Email |
arush2k12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Associate professor |
| Affiliation |
Government Medical College Hospital, Chandigarh |
| Address |
Associate professor, Department of anaesthesia and intensive care, Government Medical College Hospital, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College Hospital, Chandigarh |
| Address |
Professor, Department of anaesthesia and intensive care, Government Medical College Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia and intensive care |
| Address |
Block D, Level 5, Government Medical College Hospital, Sector 32, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Puja Saxena |
Assistant Professor, Department of anaesthesia and intensive care, Government Medical College Hospital, Sector 32, Chandigarh |
| Dr Vidhur Bhalla |
Associate Professor and Head, Department of Urology, Government Medical College Hospital, Sector 32, Chandigarh |
| Prof Sanjeev Palta |
Professor, Department of anaesthesia and intensive care, Government Medical College Hospital, Sector 32, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arush Singla |
Government Medical College Hospital, Chandigarh |
Department of anaesthesia and intensive care, Block D, Level 5, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
7009947996
arush2k12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, GMCH, Chandigarh |
Not Applicable |
| Institutional Ethics Committee, GMCH,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block with IVPCA |
Erector spinae plane block is a ultrasound guided block given in prone/lateral position in thoracic and abdominal surgeries for anaesthesia as well as analgesia. Local anaesthetic used is 0.5% bupivacaine 15 ml and analgesic used in intravenous analgesia is Morphine. Duration of IV PCA is 24 hrs. |
| Comparator Agent |
Intravenous Patient controlled Analgesia IVPCA only |
IVPCA is achieved by PCA pump that can be programmed into administering fixed amount of bolus when the patient requires/presses the trigger button. Intravenous Morphine 1mg per mL for 24 hours with maximum bolus of 15 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anaesthesiologists (ASA) physical status I-II
2. Age 18-65 years
3. BMI >18.5 to >25
4. Patient undergoing Percutaneous nephrolithotomy |
|
| ExclusionCriteria |
| Details |
1. History of relevant drug allergy
2. Patient refusal
3. History of psychiatric illness, substance abuse or medical therapies resulting in tolerance to opioids
4.Severe cardiovascular, respiratory, metabolic or neurologic disease.
5. Pregnancy
6. Untreated sepsis
7. Local infection
8. Severe coagulopathy (PTI<70% / INR>1.5)
9. Complex stone with anticipation of requiring >1 access site.
10. Prior diagnosis of chronic pain requiring daily opioid analgesic for >1 month prior to diagnosis of
nephrolithiasis.
11. Back or other musculoskeletal deformity that contributes to inaccuracy of the block placement.
12. Fibromyalgia |
|
|
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 |
| To evaluate the reduction in pain intensity up to 24 hours in post-operative period by the use of visual analogue scale in patients receiving erector spinae plane block after percutaneous nephrolithotomy. |
10 mins, 30 mins, 1hr, 4hrs, 8 hrs, 12hrs, 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate and compare the total opioid consumption over 24 hours in erector spinae plane block group as well as control group |
24 hrs |
| To calculate and compare the total dose of antiemetics over 24 in erector spinae plane block group as well as control group |
10 mins, 30 mins, 1hr, 4hr, 8hr, 12hr, 24hr |
| To note any side effects pertaining to the procedure or the drugs used in the present study |
10 mins, 30 mins, 1hr, 4hrs, 8hrs, 12hrs, 24hrs |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/04/2019 |
| 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="2"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ultrasound guided erector spinae plane (ESP) block is a regional anaesthesia technique, recently described by Forero et al for use in thoracic neuropathic pain. In ESP block, the local anaesthetic is injected, using ultrasound guidance, deep to erector spinae muscle group and superficial to a thoracic transverse process, resulting in extensive deep and superficial spread that lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicants that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia. Besides the anecdotal case reports regarding the use of erector spinae plane block in various situations, the review of literature could not disclose any randomised control trial with respect to ESPB in PCNL. Hence the present study has been designed to evaluate the efficacy of erector spinae plane block in providing post- operative analgesia to patient undergoing PCNL in comparison to well established technique of IV PCA. In the proposed study, ESPB will be performed at the level of T12 in prone position post operatively before extubation of patient, in interventional group, who underwent PCNL. Post extubation patient will be attached to IVPCA morphine pump. VAS score will be used as tool to assess the severity of pain. |