| CTRI Number |
CTRI/2024/03/064837 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment Of The Effects On Pain Free Period And Requirement Of Pain-Killer After Thoracotomy Using Either Ultrasound Guided Nerve Block In A Muscle Of Back ( Erector
Spinae) Or An Epidural Block (A Space Of Spinal Region) |
|
Scientific Title of Study
|
Comparision Between Erector Spinae Plane Block And Thoracic Epidural Block In Post Operative Analgesic Effect In Thoracotomy Patients. |
| 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 Manish Kumar Rawat |
| Designation |
Junior Resident M.D. Anaesthesiology |
| Affiliation |
King George Medical University, Lucknow |
| Address |
Resident Room,Department Of anaesthesiology ,King George Medical University, Lucknow,Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7017882946 |
| Fax |
|
| Email |
mkr8706@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Chaudhary |
| Designation |
Professor |
| Affiliation |
King George Medical University, Lucknow |
| Address |
Room No 204,Pain Management,Department of Anaesthesiology ,King George Medical University, Lucknow,Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
09415022374 |
| Fax |
|
| Email |
ajaychaudhary62@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Kumar Rawat |
| Designation |
King Georges Medical University |
| Affiliation |
King George Medical University, Lucknow |
| Address |
Resident Room,Department Of anaesthesiology ,King George Medical University, Lucknow,Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7017882946 |
| Fax |
|
| Email |
Mkr8706@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology, King Georges Medical University
Lucknow,Uttar Pradesh,226003,India |
|
|
Primary Sponsor
|
| Name |
Manish kumar rawat |
| Address |
Department of Anaesthesiology, King George Medical University Lucknow |
| Type of Sponsor |
Other [Self] |
|
|
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 Ajay kumr Chaudhary |
King Georges Medical University |
Department Of
Anaesthesiology, King
Georges Medical
University, Lucknow
UTTAR PRADESH
Lucknow,226003
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
09415022374
ajaychaudhary62@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kingh George Medical University ,Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural Block Using Landmark
Technique.
(0.25% Bupivacaine) |
Epidural Block Using Landmark Technique Is The Conventional Method For Perioperative Analgesia In Thoracotomy Patient
Route: Epidural Block Dose
0.25% bupivacaine 10 Ml
Followed By Continuous
Infusion Of 0.125% Bupivacaine Rate Of 4-6 Ml/Hr
For 12 Hours Postoperatively |
| Comparator Agent |
Ultrasound Guided Continuous
Erector Spinae Plane Block.
(0.25% Bupivacaine) |
Ultrasound Guided Continuous Erector Spinae Plane Block For Perioperative Analgesia in thoracotomy patient.
Route: Intramuscular Dose
0.25% bupivacaine 20 Ml Bolus. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I and II. Aged Between 18 To 60
Years. Patient Scheduled To Undergo Elective thoracotomy Under General Anaesthesia
|
|
| ExclusionCriteria |
| Details |
Negative Consent/Refusal.
Local Infection.
Coagulopathies.
Cardiovascular Disease, Respiratory Disease And Gastrointestinal
Disorders.
Psychiatric And Cognitive Disorders.
Allergic To Study Drug Used.
Spinal Dysraphism/Deformity.
Chronic Opioid/Analgesic User. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Measure And Compare Visual Analogue Scale Score Between Erector Spinae Block Versus Thoracic Epidural Block Effect In Post-Operative Thoracotomy Patients At 0Hour ,1Hour, 3Hour,6Hour,12hour. |
Time Of Use Of First Dose Of Rescue Analgesia At 0Hour ,1Hour, 3Hour,6Hour,12hour If VAS Score Is More Than 4.
Time Of Giving Block/Epidural. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To measure and compare various parameters in patient within 24 hours between erector spinae plane block and thoracic epidural block effect in post-operative analgesic effect of thoracotomy patients as following-
1.duration of ICU stay
2.uses of recue analgesia
3.any adverse effect or complications
4.Hemodynamic changes
|
0hour ,1hour, 3hour,6hour,12hour. Within 12 Hours
Post operatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
To Determine Which Of The Following Two Blocks: Ultrasound Guided Continous Erector Spinae Block And thoracic Epidural Block Is Superior For Postoperative Analgesia In thoracotomy patient. thoracotomy Is A Surgical Procedure Done To open chest cavity to access lungs and other midiastinal organ. Acute Pain After thoracotomy Remains A Major Problem. Chronic Pain Develops in 50 percent Patients Undergoing thoracotomy Leading To Higher Opiod Consumption With Many Adverse Effects.The Paravertebral Block And Epidural Block Are Common Blocks Used In Different Thoracic And Abdominal Surgeries With Some Complications.Studies Have Found That ESPB Affects Both The Ventral And Dorsal Rami, Leading To Blockage Of Both VIsceral And Somatic Pain. Because ESPB Is An Easy And Safe Method To Use, We Believe That It Is An Essential Part Of Anaesthesia Management For thoracotomy. Thus We Have Planned A Comparative Study Of Continous ESPB Using A Catheter And Continous Epidural Block For Postoperative Analgesia In thoracotomy patient. |