| CTRI Number |
CTRI/2025/08/092513 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing erector spinae block and surgical site local anaesthetic infiltration for pain relief after minimally invasive lung surgery |
|
Scientific Title of Study
|
Comparison of efficacy of ultrasound- guided erector spinae plane block versus local wound infiltration for post-operative analgesia in patients undergoing video-assisted thoracoscopic surgery: a double blind randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Yadav |
| Designation |
Attending Consultant |
| Affiliation |
Medanta -The Medicity |
| Address |
Department of anesthesiology and critical care
Medanta - The Medicity, sector 38
Gurgaon
HARYANA
122022
India |
| Phone |
9518089485 |
| Fax |
|
| Email |
yadavmonika248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Yadav |
| Designation |
Attending Consultant |
| Affiliation |
Medanta -The Medicity |
| Address |
Department of anesthesiology and critical care
Medanta - The Medicity, sector 38
Gurgaon
HARYANA
122022
India |
| Phone |
9518089485 |
| Fax |
|
| Email |
yadavmonika248@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Yadav |
| Designation |
Attending Consultant |
| Affiliation |
Medanta -The Medicity |
| Address |
Department of anesthesiology and critical care
Medanta - The Medicity, sector 38
Gurgaon
HARYANA
122022
India |
| Phone |
9518089485 |
| Fax |
|
| Email |
yadavmonika248@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta - The Medicity Hospital, sector 38, Gurgaon, Haryana, India 122022 |
|
|
Primary Sponsor
|
| Name |
Monika Yadav |
| Address |
Medanta The Medicity Gurgaon |
| Type of Sponsor |
Other [individual] |
|
|
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 Monika Yadav |
Medanta The Medicity |
OT number 17,18; First Floor OT complex, Department of Anaesthesiology and Critical Care, Medanta The Medicity, Sector 38
Gurgaon
HARYANA |
9518089485
yadavmonika248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
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 |
Ultrasound-guided erector spinae block will be administered as single dose at T5 vertebral level with 40 ml of 0.2% Ropivacaine between T5 vertebral level and erector spinae muscle. |
| Comparator Agent |
Local infiltration at surgical site |
Single shot subcuatenous local wound infiltration with 40 ml of 0.2% Ropivacaine at surgical site after skin closure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Informed and written consent
ASA physical status 1 and 2
Elective video-assisted thoracoscopic surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal
Infection at the site
Chronic pain patients or patients with analgesic dependence
INR more than 1.5
Difficulty in understanding or non-compliance with the quality of recovery questionnaire |
|
|
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 |
| The time to request the first post-operative rescue analgesic dose |
The time point at which the patient requests the first post-operative rescue analgesic dose in first 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total post-operative rescue analgesic requirement |
24 Hours post-operatively |
| Numerical rating score at rest and during coughing |
6 ,12 and 24 Hours post-operatively |
| Comparison of quality of recovery |
24 Hours post-operatively |
| Comparison of sedation scores |
6,12, and 24 Hours post-operatively |
| Incidence of nausea and vomitting |
Post-operative period for 24 Hours |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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 is a randomized, double blind, parallel group, single-centre trial comparing the efficacy of ultrasound-guided erector spinae plane block versus local wound infiltration for post-operative analgesia in patients undergoing video-assisted thoracoscopic surgery in 110 patients in a tertiary care centre in India. The primary outcome measure will be to determine the time to request the first post-operative rescue analgesic dose. The secondary outcomes will be total post-operative rescue analgesic requirement, comparison of quality of recovery, incidence of nausea and vomiting in the first 24 hours post-operatively and numerical rating score at rest and during coughing, comparison of sedation scores at 6, 12, and 24 hours post-operatively |