| CTRI Number |
CTRI/2024/11/076384 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Ultrasound-Guided Pain Block to Traditional Methods for Pain Relief After Thoracolumbar Spine Surgery |
|
Scientific Title of Study
|
Comparative Study Of Ultrasound Guided Bilateral Erector Spinae Plane Block versus Conventional method For Post Operative Analgesia In Thoracolumbar Spine Surgeries. |
| 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 SALONI MANDHANE |
| Designation |
JR1 ANAESTHESIA |
| Affiliation |
MGM Medical College |
| Address |
Department of Anaesthesia
MGM Medical College N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8668761322 |
| Fax |
|
| Email |
saloni.mandhane08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHALE PRAMOD |
| Designation |
HOD AND PROFESSOR ANAESTHESIA |
| Affiliation |
MGM Medical College |
| Address |
Department of Anaesthesia
MGM Medical College N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888819021 |
| Fax |
|
| Email |
pramod.bhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SALONI MANDHANE |
| Designation |
JR1 ANAESTHESIA |
| Affiliation |
MGM Medical College |
| Address |
Department of Anaesthesia,
MGM Medical College N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8668761322 |
| Fax |
|
| Email |
saloni.mandhane08@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM MEDICAL COLLEGE AURANGABAD |
|
|
Primary Sponsor
|
| Name |
MGM MEDICAL COLLEGE |
| Address |
MGM MEDICAL COLLEGE, N6 CODCO AURANGABAD 431003 |
| Type of Sponsor |
Private medical college |
|
|
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 SALONI MANDHANE |
MGM HOSPITAL |
Department of Anaesthesia,
MGM Medical College, N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA |
8668761322
drsalonimandhane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
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 |
| Comparator Agent |
conventional method for post operative analgesia |
Inj. Diclofenac 1mg/kg in 100ml NS will be given 30 mins prior to extubation. |
| Intervention |
erector spinae plane block |
E ESP block will be given using following technique, the operative level will be identified and marked with C arm. After ensuring complete asepsis, a linear high‑frequency US probe in a sterile sheath will be placed approximately 3 cm lateral to the midline of the spinous process in a longitudinal parasagittal orientation. The erector spinae muscle will be identified at the tip of the transverse process of the vertebra, and a 10‑cm 22‑G stimuplex needle will be inserted at the level of surgery via the in‑plane technique in the cephalic‑caudal direction until bone contact with the tip of the transverse process will be reached. The correct needle placement will be confirmed by hydro‑dissection with saline, and 15mL of 0.25% ropivacaine bilaterally with 8mg dexamethasone will be administered after negative aspiration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH ASA GRADE 1,2,3
PATIENTS UNDERGOING ELECTIVE THORACOLUMBAR SPINE SURGERIES |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
PATIENT WITH COAGULOPATHIES, DRUG ALLERGIES, PSYCHOLOGICAL ILLNESS
AND PATIENT UNDERGOING ENDOSCOPIC SPINE SURGERIES |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the effectiveness of ultrasound guided erector spinae plane block using Visual Analogue Scale (VAS)
|
24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the Patient satisfaction score will be documented using Likert Scale. (1 very dissatisfied, 2 dissatisfied, 3 satisfied, 4 very satisfied) will be noted at 24h. |
24 hour |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="2"
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
|
The study compares the efficacy of ultrasound-guided bilateral erector spinae plane block (ESPB) with conventional analgesic methods for postoperative pain management in thoracolumbar spine surgeries. It aims to evaluate pain relief, opioid consumption, and overall patient satisfaction. The ultrasound-guided ESPB is expected to provide more targeted analgesia, potentially reducing the need for systemic opioids and minimizing side effects. Key metrics include pain scores at various intervals post-surgery, opioid requirements, and any complications arising from the analgesic techniques. The findings could inform clinical practices and improve pain management strategies in spinal surgery. |