| CTRI Number |
CTRI/2024/07/070190 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Analgesic efficacy of ultrasound guided
erector spinae fascial plane block in lumbar
spine surgeries |
|
Scientific Title of Study
|
Analgesic efficacy of ultrasound guided
erector spinae fascial plane block in lumbar
spine surgeries- a prospective randomised
controlled 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 |
Anuja Kumari Saha |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Kalyani |
| Address |
Room no. 1060,Department of Ananesthesiology,All India Institute of Medical Sciences, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
8250127713 |
| Fax |
|
| Email |
anujakumarisaha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Kalyani |
| Address |
Room no. 1060,Department of Ananesthesiology,All India Institute of Medical Sciences, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
9836893073 |
| Fax |
|
| Email |
anjum.anesth@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anuja Kumari Saha |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Kalyani |
| Address |
Room no. 1060,Department of Ananesthesiology,All India Institute of Medical Sciences, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
8250127713 |
| Fax |
|
| Email |
anujakumarisaha1@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Kalyani,NH-34 connector,Basantapur,Saguna,Kalyani,Nadia,West Bengal,741245, Country-India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Kalyani |
| Address |
NH-34 connector,Basantapur,Saguna,Kalyani,Nadia,West Bengal,741245, Country-India |
| 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 |
| Dr Anuja Kumari Saha |
All India Institute of Medical Sciences, Kalyani |
Room no. 1060, Department of Anaesthesiology
Nadia
WEST BENGAL |
8250127713
anujakumarisaha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
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 spinal fascial plane block |
Bilateral Erector spinal fascial plane block will be given.Drugs used are 20ml of 0.25% bupivacaine( maximum dose should not cross 2mg/kg) and 8mg of dexamethasone. |
| Comparator Agent |
Intravenous fentanyl with the aid of patient controlled analgesia pump |
A basal infusion will be given post operative with intravenous fentanyl via PCA pump in dose of 10 mcg/hr
infusion with 15 min lock out time and bolus of 20 mcg can be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA I and ASA II
2) Scheduled for elective lumbar spine surgery (PLIF and TLIF)
3)Lumbar spine surgery involving not more than three levels |
|
| ExclusionCriteria |
| Details |
1)Patients with pre-existing neurological deficits
2)Patients undergoing emergency or revision lumbar spine surgery
3)Patients with contraindications to erector spinae block
4) Patients with opioid dependence.
5)Patient with scoliosis. |
|
|
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 |
1)Time to first request of analgesia. Postoperative pain scores assessed using Visual Analog Scale (VAS) at 6,12 and 24 hours postoperatively
2)Total opioid consumption in first 24 hours postoperatively |
In first 24 hours postoperatively at 6th hour,12th hour and 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incision response
2.Surgical field experience
3.Postoperative nausea and vomiting (PONV)
4.Time to ambulation post surgery.
5.Patient satisfaction with postoperative pain management. |
First 24 hours postoperative |
|
|
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)
|
01/08/2024 |
| 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="11"
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
|
Aim of this study is to assess the analgesic efficacy of ultrasound guided erector spinae block with standardized multimodal analgesic technique in patients undergoing posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgeries.Assessing the impact of ESB on opioid consumption, postoperative nausea and vomiting (PONV), time to ambulation, length of hospital stay, and patient satisfaction. Previous studies show promising results, however proper study with adequate sample size and assessment of association with any possible complications is yet to be assessed. One group of patients will receive bilateral erector spinae block followed by i.v fentanyl via PCA pump in post operative period and other group will not receive any block and will get i.v fentanyl via PCA pump in post operative period.Then we will assess time to first request of analgesia, postoperative pain scores assessed using Visual Analog Scale (VAS) at specified time points and total opioid consumption in the first 24 hours postoperatively. |