| CTRI Number |
CTRI/2021/03/031682 [Registered on: 03/03/2021] Trial Registered Prospectively |
| Last Modified On: |
28/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the effectiveness of pain relief by Thoracolumbar interfascial plane block in patients undergoing spinal surgeries |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of ultrasound guided thoracolumbar interfascial plane block in adult patients undergoing lumbar spinal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ananya Sharma |
| Designation |
PG Resident |
| Affiliation |
Department of Anaesthesia and intensive care Vmmc and Safdarjung hospital |
| Address |
Department of Anaesthesiology and intensive care, Vmmc and Safdarjung hospital
Vmmc and Safdarjung Hospital ,New Delhi,110029
New Delhi
DELHI
110010
India |
| Phone |
918130063105 |
| Fax |
|
| Email |
ananya101995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Saini |
| Designation |
Consultant |
| Affiliation |
Department of Anaesthesia and intensive care Vmmc and Safdarjung hospital |
| Address |
Department of Anaesthesia and intensive care,Vmmc and Safdarjung hospital,New Delhi
Vmmc and Safdarjung hospital ,New delhi,110029
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
011-26163072 |
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananya Sharma |
| Designation |
PG Resident |
| Affiliation |
Department of Anaesthesia and intensive care Vmmc and Safdarjung hospital |
| Address |
Vmmc and Safdarjung hospital,New Delhi
Vmmc and Safdarjung hospital,New Delhi 110029
New Delhi
DELHI
110010
India |
| Phone |
918130063105 |
| Fax |
|
| Email |
ananya101995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia and intensive care ,Vmmc and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia and intensive care |
| Address |
Orthopaedic spine surgery OT and Neurosurgery OT,New Emergency block,Vmmc and Safdarjung hospital ,New Delhi 110010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Guru Gobind Singh indraprastha university |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya Sharma |
Vmmc and Safdarjung hospital,New Delhi 110010 |
OT-12,Orthopaedic spine OT and OT -2,Neurosurgery OT, New Emergency block, Department of anaesthesia and intensive care Safdarjung Hospital
New Delhi
DELHI |
8130063105
ananya101995@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: G959||Disease of spinal cord, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Thoracolumbar interfacial plane block |
Efficacy of the block in patients undergoing spinal surgeries.After prone positioning the patient , Ultrasound guidedThoracolumbar interfascial plane block will be given.Intraoperative monitoring will be done on every 15 min.Once patient is shifted to post operative care unit,morphhine will be given using patient controlled analgesia pump for 24 hours.With bolus dose set as 1 ml and lock out time of 20 minutes.Following parameters will be assessed at 0,2,4,6,12 and 24 hours from surgery :
1.vitals of the patient
2.time to first analgesic dose from surgery
3.No of times pca button pushed and total morphine dose consumption
4.incidence of nausea and vomiting
|
| Comparator Agent |
Thoracolumbar interfascial plane block |
To comparatively evaluate the efficacy of the ultrasound guided thoracolumbar interfascial plane block in adult patients undergoing lumbar spinal surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 scheduled to undergo elective spinal surgeries |
|
| ExclusionCriteria |
| Details |
History of allergy to local anaesthesia
Contraindications to the block(coagulaopathies,anticoagulants)
Inability to understand pain scale
Inability to PCA pump
Body mass index >30
Previous lumbar spinal surgeries |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of the ultrasound guided thoracolumbar interfascial plane block in patients undergoing lumbar spinal surgeries |
at baseline,2,4,6,12,24 and 48 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the following parameters in adult patients undergoing lumbar spinal surgeries in both the groups
1.to compare the time to first analgesic in each group
To compare the total morphine consumption over 24 hrs in both the groups
To compare the patient satisfaction in terms of quality of pain relief using the likert scale |
At 0,2,4,6,8,10,12,24 hrs of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2021 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Published at VMMC and Safdarjung hospital |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To comparatively evaluate the efficacy of the ultrasound guided thoracolumbar interfascial plane block in adult patients undergoing lumbar spinal surgeries. |