| CTRI Number |
CTRI/2023/07/055308 [Registered on: 18/07/2023] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study erector spinae block and epidural anesthesia technique for pain relief in lung surgery |
|
Scientific Title of Study
|
A study to evaluate the analgesic efficacy of erector spinae plane block with continuous thoracic epidural for patients undergoing thoracotomy surgeries |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aseem Gargava |
| Designation |
Assistant Professor(Cardiac Anesthesia) |
| Affiliation |
Gandhi medical college bhopal |
| Address |
Department of anesthesia, 2nd floor, A block , Hamidia hospital, near royal market, bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aseem Gargava |
| Designation |
Assistant Professor(Cardiac Anesthesia) |
| Affiliation |
Gandhi medical college bhopal |
| Address |
Department of anesthesia, 2nd floor, A block , Hamidia hospital, near royal market, bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aseem Gargava |
| Designation |
Assistant Professor(Cardiac Anesthesia) |
| Affiliation |
Gandhi medical college bhopal |
| Address |
Department of anesthesia, 2nd floor, A block , Hamidia hospital, near royal market, bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
|
Source of Monetary or Material Support
|
| gandhi medical college and hamidia hospital, Bhopal |
|
|
Primary Sponsor
|
| Name |
Aseem Gargava |
| Address |
department of anesthesiology, 2nd floor, A block, Hamidia hospital, Bhopal |
| 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 Aseem Gargava |
Gandhi medical college |
Department of anesthesiology, room no.201, 2nd floor , A block, Gandhi Medical college and hamidia hospital, Bhopal
Bhopal
MADHYA PRADESH |
8860494714
aseemgargava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, GMC bhopal |
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 |
a block is administered 15 minutes after general anesthesia induction, and post operative pain will be noted. |
| Comparator Agent |
Thoracic epidural anesthesia |
this will be administered 15 minutes before general anesthesia induction and post operative pain will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
all patients of above age group posted for thoracotomy surgeries. |
|
| ExclusionCriteria |
| Details |
Patient refusal, pregnancy, coagulopathies, seizure disorder, ASA grade III and above, patients on anticoagulants, drug allergy to bupivacaine or history of cardiac or hepatic or renal disorder. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| percentage decrease in pain using visual analogue scale |
immediate postyoperative period followed by every hourly for next 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total rescue analgesic requirement |
in first 48 hours (in mg) |
| percentage change in spirometry from baseline |
every one hourly in post operative period till 48 hours. |
| total duration of ventilation |
in postoperative period |
| Total ICU stay |
in number of days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2023 |
| Date of Study Completion (India) |
09/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: Erector spinae plane block is a novel technique of analgesia especially in the thoracic dermatomes. Multiple studies have been done in the past but for sternotomy in cardiac surgeries. Their is a paucity in literature for its analgesic response in thoracotomy and lung surgeries. we thought it would be worthwhile to compare its analgesic efficacy with that of conventional thoracic epidural technique and also to look for any complications or side effects if any. AIM : To study the analgesic efficacy of erector spinae plane block and continous thoracic epidural analgesia in patients undergoing thoracotomy surgeries Methodology: patient will be induced using standard general anaesthesia technique followed by administration of erector spinae plane block or thoracic epidural depending upon whichever group the patient is alloted to which will be decided by randomisation using sealed envelope technique. The principal investigator will be administering the block and the assesor will be coinvestigator who will be blinded regarding the procedure. The data will be assessed by a third investigator who is unaware of the group allotment, block administered and the data collected. Statistical analysis will be done using SPSS of current version. continuous variables will be measured according to appropriate tools of analysis. Limitations: postoperative pain after 48 hours will not be analysed.
Pain during movement or positioning will not be analysed. Patient requiring prolong ventilation (>48hours) or patient re intubated in first 48 hours will be excluded from the study.
|