| CTRI Number |
CTRI/2025/03/083676 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Pain Relief Methods After Spine Surgery: ESP Block vs. Local Injections |
|
Scientific Title of Study
|
Postoperative Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plane Block versus Local Infiltration
Analgesia in Patients Undergoing Lumbar Spine Fixation under General Anaesthesia: A Randomised Double BlindTrial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Saxena |
| Designation |
Co-Chairperson and Senior Consultant |
| Affiliation |
Sir Gangaram Hospital, Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital, Delhi
Central
DELHI
110060
India |
| Phone |
9810373301 |
| Fax |
|
| Email |
Rakeshsaxena3009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddharth Goyal |
| Designation |
DNB Trainee Post Diploma |
| Affiliation |
Sir Gangaram Hospital, Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital, Delhi
Central
DELHI
110060
India |
| Phone |
8076128103 |
| Fax |
|
| Email |
Dr.siddharth.goyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddharth Goyal |
| Designation |
DNB Trainee Post Diploma |
| Affiliation |
Sir Gangaram Hospital, Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital, Delhi
Central
DELHI
110060
India |
| Phone |
8076128103 |
| Fax |
|
| Email |
Dr.siddharth.goyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Anaesthesiology, Pain & Perioperative Medicine, 5th Floor, Sir Gangaram Hospital, Old Rajinder Nagar, New Delhi-110060 |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, 5th Floor,SGRH, Delhi-110060 |
| 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 Rakesh Saxena |
Sir Ganga Ram Hospital |
5TH FLOOR, SSRB Block, Sir Ganga Ram Hospital, Rajinder Nagar, Delhi-110060
Central
DELHI |
9810373301
rakeshsaxena3009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospital |
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(ESP) Block Group |
The patient will receive a USG-guided bilateral ESP block with 15 ml of 0.25% levo-bupivacaine on each side intraoperatively. |
| Comparator Agent |
Incision Site Infiltration of Local Anaesthesia (LIA) |
The patient will receive peri incisional infiltration analgesia with 30 ml of 0.25% levo-bupivacaine intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 or 2 level spine fixation surgeries
Body mass index (BMI) - 18-30 kg/m2
American Society of Anaesthesiology (ASA) Grade - I & II |
|
| ExclusionCriteria |
| Details |
Refusal of consent to participate in study
More than 2 level of spine fixation surgery
Coagulation disorders(INR more than 1.5)
History of hypersensitivity to local or systemic anaesthetic agents
Block Failure |
|
|
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 |
| First rescue analgesia |
in postoperative period within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters, Postoperative pain scores, Functional recovery,
Patient satisfaction & PONV |
At 0.5, 1, 2, 6, 12, 24
hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2025 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 randomized, double-blind, parallel-group, single-center trial compares the efficacy of ultrasound-guided erector spinae plane (ESP) block to local infiltration analgesia (LIA) with 0.25% Levobupivacaine in patients undergoing lumbar spine fixation surgery under general anesthesia. The primary outcome is the time to first rescue analgesia post-surgery. Secondary outcomes include hemodynamic parameters (mean arterial pressure and heart rate) at various intervals up to 24 hours post-surgery, postoperative pain scores using the Numerical Rating Scale (NRS), functional recovery (time to first ambulation and self-voiding), patient satisfaction for pain relief using a 5-point Likert scale, and postoperative nausea and vomiting (PONV) scores at 0.5, 1, 2, 6, 12, and 24 hours post-surgery. |