| CTRI Number |
CTRI/2022/07/044362 [Registered on: 26/07/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| 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
|
Study to compare continuous erector spinae plane block and thoracic epidural on pain after lung surgery |
|
Scientific Title of Study
|
The comparison of analgesic efficacy of continuous erector spinae plane block against thoracic epidural analgesia in post thoracotomy patients- a prospective randomised controlled double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowjanya K |
| Designation |
Resident |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Plot no- 80,81 ,Opp HRC Pride, Brundavan hills, Road no 2 ,near Rajadhani school, Nizampet
Medchal
TELANGANA
500090
India |
| Phone |
8639370632 |
| Fax |
|
| Email |
sowjanyakutty0209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmaja Durga |
| Designation |
Professor |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Department of Anaesthesiology
NIMS, Punjagutta, Hyderabad
Telangana
Hyderabad
TELANGANA
500082
India |
| Phone |
9440387299 |
| Fax |
|
| Email |
padmajanims@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowjanya K |
| Designation |
Resident |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Plot no- 80,81 ,Opp HRC Pride, Brundavan hills, Road no 2 ,near Rajadhani school, Nizampet
Medchal
TELANGANA
500090
India |
| Phone |
8639370632 |
| Fax |
|
| Email |
sowjanyakutty0209@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams institute of medical sciences,Punjagutta, Hyderabad,Telangana, 500082 |
|
|
Primary Sponsor
|
| Name |
Nizams institute of medical sciences |
| Address |
Department of Anaesthesiology and critical care, NIMS, Punjagutta, Hyderabad- 500082 |
| 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 Sowjanya K |
Nizams institute of medical sciences |
Department of Anaesthesiology, Nizams institute of medical sciences, Punjagutta, Hyderabad,Telangana,
Hyderabad
TELANGANA |
8639370632
sowjanyakutty0209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS 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 |
Continuous erector spinae plane block |
20ml of 0.5% ropivacaine bolus followed by continuous infusion of 0.25% ropivacaine @ 6ml/hr intraoperatively followed by 0.125% ropivacaine @6ml/hr postoperatively for 24hrs |
| Comparator Agent |
Thoracic epidural analgesia |
3ml of 0.5% ropivacaine bolus followed by continuous infusion of 0.25% ropivacaine @ 6ml/hr intraoperatively followed by 0.125% ropivacaine @6ml/hr postoperatively for 24hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status: 2,3
2. Age Group: Adults and older adults (18-60 years)
3. Both sexes |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to the drugs used in the study
2. Patients with diabetic neuropathy, psychiatric illness, and coagulation disorders
3. Patients with severe hepatic or renal insufficiency
4. Spinal deformities
5.Infection at the site of injection
6. Age <18 and >60 years
7. ASA 4
8. Pregnancy
9. Emergency surgery |
|
|
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 |
| Post operative analgesia as assessed by Visual Analogue Scale (VAS)pain scores at rest and while coughing at 0, 2, 4, 8, 24 and 48 h postoperatively. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SPI, Haemodynamics at skin incision, rib retraction
SPI based fentanyl- total intraop fentanyl
PaO2- baseline, after intubation-2lung, one lung 15 min, 30 min, 45min, 2 lung
SpO2, ETCO2
Pain after Extubation
Postop static and dynamic VAS
Postop rescue analgesia
Postop PFT |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomised controlled double blinded study comparing the analgesic efficacy of thoracic epidural analgesia against ultrasound guided continuous erector spinae plane block( ESPB) in post thoracotomy patients. After obtaining written approval, the patients will be randomised into intervention (receiving ESP block) and control group (receiving thoracic epidural analgesia). The ultrasound guided ESPB and thoracic epidural analgesia will be performed before the induction of general anaesthesia. General anaesthesia will be conducted according to the institutional protocol. In postoperative period, the degree of pain will be assessed using VAS on a scale of 0 indicating no pain and 10 indicating the most severe pain ever experienced. Patient will receive rescue analgesia when VAS was > or equal to 4 or on demand. The time to first administration of analgesic will be noted. Postoperative pulmonary function tests and total 48-hour analgesic requirement will also be recorded. |