CTRI Number |
CTRI/2021/01/030284 [Registered on: 06/01/2021] Trial Registered Prospectively |
Last Modified On: |
05/01/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
ERECTOR SPINAE BLOCK COMPARING WITH THORACIC EPIDURAL ANAESTHESIA IN OPEN THORACIC SURGERY LIKE THORACOTOMY FOR RELIEVEMENT OF POSTOPERATIVE PAIN |
Scientific Title of Study
|
COMPARISON OF ERECTOR SPINAE BLOCK VERSUS THORACIC EPIDURAL ANAESTHESIA FOR
POSTOPERATIVE PAIN MANAGEMENT IN ADULT PATIENTS UNDERGOING
THORACOTOMY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Meka Sree Pooja |
Designation |
POSTGRADUATE |
Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL MYSURU |
Address |
Junior resident (postgraduate)
Department of anaesthesiology
JSS medical college and hospital
Ramachandra Agrahara
Mysuru
Karnataka
570004
India
Mysore KARNATAKA 570004 India |
Phone |
9493682891 |
Fax |
|
Email |
sreepoojareddy.meka@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manjula BP |
Designation |
Professor |
Affiliation |
jss medical college and hospital mysuru |
Address |
Dr Manjula BP
Professor
Department of anaesthesiology
JSS medical college and hospital MG road agrahara
mysuru
Karnataka
570004
India
Mysore KARNATAKA 570004 India |
Phone |
9845501226 |
Fax |
|
Email |
bpmanjula5@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manjula BP |
Designation |
Professor |
Affiliation |
jss medical college and hospital mysuru |
Address |
Dr Manjula BP
Professor
Department of anaesthesiology
JSS medical college and hospital MG road agrahara
mysuru
Karnataka
570004
India
Mysore KARNATAKA 570004 India |
Phone |
9845501226 |
Fax |
|
Email |
bpmanjula5@gmail.com |
|
Source of Monetary or Material Support
|
JSS MEDICAL COLLEGE AND HOSPITAL, MYSURU |
|
Primary Sponsor
|
Name |
JSS MEDICAL COLLEGE AND HOSPITAL |
Address |
JSS MEDICAL COLLEGE AND HOSPITAL, MG ROAD, AGRAHARA, MYSURU |
Type of Sponsor |
Private medical college |
|
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 MEKA SREE POOJA |
JSS MEDICAL COLLEGE AND HOSPITAL |
PATIENTS OF CARDIOTHORACIC AND VASCULAR SURGERY DEPARTMENT, THIRD FLOOR, OPERATION THEATRE COMPLEX,MG ROAD,AGRAHARA ,MYSURU,KARNATAKA
Mysore KARNATAKA |
9493682891
sreepoojareddy.meka@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JSS MEDICAL COLLEGE AND HOSPITAL MYSURU |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J948||Other specified pleural conditions, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Erector spinae block |
Neural blocks like erector spinae block with continuous infusion of local anaesthetic through the catheter will be given 48 hours after extubation to the patients for postoperative pain relief. |
Comparator Agent |
NIL |
NIL |
Intervention |
Thoracic epidural anaesthesia |
Through Thoracic epidural, continuous infusion of local anaesthetic through the epidural catheter will be given 48 hours after extubation to the patients for postoperative pain relief |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of ASA physical status class 1 undergoing thoracotomy |
|
ExclusionCriteria |
Details |
1. Infection at the site of needle puncture
2. Blood or cerebrospinal fluid tap during the procedure
3. Patients on anticoagulation
4. Patients with bleeding disorders
5. Patients refusal |
|
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 |
To study the effectiveness of regional neural blocks in providing postoperative pain relief for the patients undergoing thoracotomy |
Pain assessment and hemodynamic parameters monitoring post extubation will be done at 0,3,6,12,24,36,48 hours respectively. Based upon VAS pain score patients pain relief will be assessed |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessment of incentive spirometry
Incidence of nausea, vomiting,pruritis
Duration of ICU stay |
At 0,3,6,12,24,36,48 hours incentive spirometry and occurence of nausea vomiting will be documented |
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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
|
N/A |
Date of First Enrollment (India)
|
10/01/2021 |
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="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Following approval from the Institutional Ethical Committee, informed written consent will be taken from 64 patients of American Society of Anaesthesiologists (ASA) Physical status class I/II undergoing elective thoracotomies. A thorough pre anaesthetic evaluation will be done 24 hours prior to the procedure. On the day of surgery, a single anesthesiologist performs either erector spinae block or thoracic epidural anaesthesia. A radial arterial line and an 18 G IV cannula will be inserted and the patient is connected to standard monitors such as noninvasive blood pressure, electrocardiography (ECG), and pulse oximetry (SpO2).Under standardized general anaesthesia protocol, patient will be preoxygenated with 100% oxygen and premedicated with ondansetron 0.1mg/kg, midazolam 0.02mg/kg, glycopyrrolate 0.01mg/kg and analgesics like fentanyl 2mcg/kg is used and induced with propofol 2mg/kg and muscle relaxants vecuronium 0.1mg/kg. Then patients are going to be intubated with double lumen endobronchial tubes of respective sizes and connected to mechanical ventilator. Double lumen endobronchial tubes will be kept insitu and extubation is done after 2 hours post-surgery. After giving general anaesthesia, based upon computer generated randomized sequence, one group of patients will receive thoracic epidural and another group will receive erector spinae block. Thoracic epidural catheter will be inserted under strict aseptic precautions. An 18 G Tuohy needle is inserted at T6/T7 intervertebral space to identify epidural space using the loss of resistance technique. 20G catheter is threaded 3–4 cm into the epidural space, test dose i.e. 2% lignocaine plus 1:1000 adrenaline 3ml is given after the negative aspiration for blood or cerebrospinal fluid, followed by a continuous infusion of 0.125% sensorcaine plus 2 micrograms per ml fentanyl given at the rate of 5 ml//hour till 48 h postextubation.
Ultrasound guided erector spinae block will be performed under the strict aseptic precautions. A highâ€frequency linear ultrasound transducer 12Hz, is placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) are identified superior to the hyperechoic transverse process. Using in†plane approach an 18 G Tuohy needle is inserted in caudal–cephalad direction, until the tip is deep to erector spinae muscle as evidenced by visible hydrodissection below the muscle plane, on injection of 5 ml of normal saline. A 20 G epidural catheter is threaded 3-4 cm in cephalad direction, after the negative aspiration for blood, followed by continuous infusion of 0.125% sensorcaine plus 2 micrograms per ml fentanyl given at the rate of 5 ml/hour till 48 h post extubation.
Rescue analgesia will be given to patient if visual analog score is >4. First rescue analgesic given to the patient will be paracetamol 20 mg/kg dose. The second rescue analgesic will
be ketorolac 0.5 mg/kg dose diluted in normal saline and administered slowly. |