| CTRI Number |
CTRI/2024/03/064173 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study comparing the modified para vertebral block at the retrolaminar site versus the inter fascial block deep to the erector spinae muscles using ultrasonography for post operative pain relief in patients undergoing percutaneous nephrolithotomy. |
|
Scientific Title of Study
|
Ultrasound guided retrolaminar block versus ultrasound guided erector spinae plane block for post operative analgesia in percutaneous nephrolithotomy; a randomised comparative 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 |
Dr Birina Kakaty |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital, Guwahati Kamrup Metro - 781032, Assam
Kamrup
ASSAM
781032
India |
| Phone |
8638982580 |
| Fax |
|
| Email |
birinakakaty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Professor and Head of the department |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Guwahati Kamrup Metro - 781032 Assam
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birina Kakaty |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Guwahati Kamrup Metro - 781032 Assam
Kamrup
ASSAM
781032
India |
| Phone |
8638982580 |
| Fax |
|
| Email |
birinakakaty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital Kamrup Metro-781032 Assam |
|
|
Primary Sponsor
|
| Name |
Dr Birina Kakaty |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Guwahati Kamrup Metro -781032 Assam |
| 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 Birina Kakaty |
Gauhati Medical College and Hospital |
Department of Anesthesiology and Critical Care , GMCH, Bhangagarh, Guwahati, Kamrup Metro -781032, Assam.
Kamrup
ASSAM |
8638982580
birinakakaty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gauhati Medical College and Hospital, Guwahati |
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 |
| Intervention |
Erector spinae plane block using injection ropivacaine. |
Dose - 20ml of 0.25% concentration.
Route of administration - Inter fascial plane deep to erector spinae muscle using ultrasonography.
Total duration of analgesia - Time from injection of the drug to the patients first request for rescue analgesia. |
| Comparator Agent |
Retrolaminar block using injection ropivacaine. |
Dose - 20ml of 0.25% concentration.
Route of administration - Inter fascial plane at the retro laminar site using ultrasonography.
Total duration of analgesia - Time from injection of the drug to the patients first request for rescue analgesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology Physical Status 1, 2 and 3
Scheduled for elective percutaneous nephrolithomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give consent
2. Allergy to the study drugs.
3. Infection at the site of the block.
4. Cardiovascular diseases
5. Chronic obstructive pulmonary disease.
6. Other major systemic illness.
7. Patient having history of substance abuse
8. Patient with delirium and on antipsychotic medication.
9. Disorder of coagulation.
10. Patients having chronic pain and on chronic analgesic medications.
|
|
|
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 compare the total duration of analgesia. |
Time from injection of the drug to the patients first request for rescue analgesia or NRS score more than 4, between the two groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the pain NRS scores at rest & during cough postoperatively after extubating between the two groups.
2.To calculate the total analgesic requirement in first 24hours between the two groups.
3.To compare any complications between the two groups. |
Outcome will be assessed at the following time intervals at rest & on coughing.
0 hour, 30 minutes , 1 hour , 2 hours , 4 hours, 6hours, 8 hours , 16 hours & 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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 will be a prospective randomised, double blinded, parallel group, single hospital, comparative study comparing the effects of ultrasound guided erector spinae plabe block versus ultrasound guided retrolaminar block on post operative analgesia in patients undergoing percutaneous nephrolithotomy. The null hypothesis of our study is that there is no difference in the duration of analgesia after erector spinae plane block and retrolaminar block in patients undergoing percutaneous nephrolithotomy.
AIM:
To compare the analgesia after ultrasound guided unilateral retrolaminar block with
ultrasound guided unilateral erector spinae plane block in patients undergoing
percutaneous nephrolithotomy. PRIMARY OBJECTIVE:
To compare the duration of analgesia , that is, the time from injection of the drug
administration to the patients first request for rescue analgesia or NRS score > 4,
between two groups. SECONDARY OBJECTIVE: 1. To compare the pain NRS scores at rest and during cough
postoperatively after extubating, between two groups. 2. To calculate the total analgesic requirement in first 24hours between
two groups. 3. To compare any complications, like , post operative nausea and
vomiting, post operative shivering, pneumothorax and any other between
the two groups.
REFERENCES 1.Role of Erector Spine Plane Block for Postoperative Analgesia in Patients
Undergoing Percutaneous Nephrolithotomy Bhatia R, Asthana V, Sarpal R,
Bindal K - MAMC J Med Sci (mamcjms.in) 2.Comparison of erector spinae plane block and local anaesthetic infiltration
of the incision site for postoperative analgesia in percutaneous
nephrolithotomy – A randomised parallel-group study - PMC (nih.gov) 3.Craig DB. Post-operative recovery of pulmonary function. Anesth Anal
1981;60:46 -52. 4.Comparison of Clinical Efficacy and Anatomical Investigation between
Retrolaminar Block and Erector Spinae Plane Block (hindawi.com) 5.Effects of erector spinae plane block and retrolaminar block on analgesia for
multiple rib fractures: a randomized, double-blinded clinical trial –
ScienceDirect 6.Safety and effectiveness of ultrasound-guided RLB and ESPB | JPR
(dovepress.com) 7.International Journal of Medical Science in Clinical Research and Review
(ijmscrr.in) 8. Kerai S, Saxena KN, Taneja B. : What is new? Indian J Anaesth.
2017;61:200-14 9.Erector Spinae Plane Block - StatPearls - NCBI Bookshelf (nih.gov) 10. The ultrasound-guided retrolaminar block - PubMed (nih.gov) |