| CTRI Number |
CTRI/2024/03/064389 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Erector spinae block for pain relief |
|
Scientific Title of Study
|
Effects of erector spinae block on the postoperative quality of recovery after Gender Reassignment chest surgeries: a prospective randomized double-blinded 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 |
Dr Krishna Prasad T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Centre, Ammapettai, Kancheepuram district, Tamilnadu.
Kancheepuram TAMIL NADU 603103 India |
| Phone |
09944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Krishna Prasad T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Centre, Ammapettai, Kanchipuram District, Tamilnadu.
Kancheepuram TAMIL NADU 603103 India |
| Phone |
09944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krishna Prasad T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Centre, Ammapettai, Kanchipuram District, Tamilnadu.
TAMIL NADU 603103 India |
| Phone |
09944579455 |
| Fax |
|
| Email |
drkrishna86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri sathya sai medical college and research centre |
|
|
Primary Sponsor
|
| Name |
Krishna prasad T |
| Address |
professor,
shri sathya sai medical college,
Srhi balaji vidyapeeth university |
| Type of Sponsor |
Other [self funding] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| krishna prasad T |
Shri Sathya Sai Medical College |
Ammapettai, Kancheepuram. Kancheepuram TAMIL NADU |
09944579455
drkrishna86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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 |
| Comparator Agent |
Intraoperative blocks |
Erector spinae block given bilaterally using 23Guage needle, drug used is ropivacaine 0.5% 10 ml in erector spinae plane block. Total duration 24 hours followed up for the effect of block. |
| Intervention |
Ropivociane in erector spinae block |
to see the efficacy. total duration of 24 hours followed up for the effective block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes and for transfeminine surgeries |
|
| ExclusionCriteria |
| Details |
not willing for injections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| first onset of pain, rescue analgesia |
pain assessed at time intervals like 2, 4, 6,8,12 and 24 hours after the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications for the procedure |
at intervals in 4, 8, 12 & 24 hours noted. after rescue analgesia |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Regional anesthesia techniques in addition to general anesthesia for postoperative pain have been in practice. Those techniques are performed under ultrasound guidance as part of multimodal analgesia in both intraoperative and postoperative periods. Among the supportive techniques, Erector spinae plane block (ESPB) was first defined for thoracic neuropathic pain treatment in 2016 and was found to provide sufficient postoperative analgesia in thoracic, breast, bariatric, and upper abdominal surgeries concerning the anatomical level applied 1. Although the exact mechanism of ESPB is unknown, it has gained popularity as a result of the growing number of randomized trials that have demonstrated its effectiveness. Statistically meaningful increases in postoperative analgesia and reductions in opioid intake, however, can only be clinically significant if they promote a better recovery quality. Whether a relationship exists between ESPB and postoperative recovery quality is still unknown, especially in bilateral breast or chest surgeries. Postoperative recovery after surgery and anesthesia is a complex and multidimensional process 2. Inadequate recovery quality negatively influences both the patient and the medical team. Although a delayed return to normal activities may produce dissatisfaction with the medical service received prolonged recovery or delayed discharge also significantly impacts the medical team’s resource utilization 3. Therefore, we hypothesized that ESPB could also provide a better quality of recovery in patients who underwent Reassignment Chest surgery, as it allows effective post-operative pain control. The primary outcome of this study was to evaluate the effectiveness of ultrasound-guided ESPB on postoperative quality of recovery after surgery using the 40-item quality of recovery (QoR-40) questionnaire. Evaluation of the effects of ESPB on postoperative pain, opioid con- consumption, and nausea and vomiting was determined as the further outcome of the study. |