CTRI Number |
CTRI/2023/07/055014 [Registered on: 10/07/2023] Trial Registered Prospectively |
Last Modified On: |
02/02/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison of efficacy in pain relief ,change in pulse rate, blood pressure and surgeons’ satisfaction between general anaesthesia with local anaesthetic in between lumbar vertebra and erector spine muscle and local anaesthetic injected in spinal space in lumbar spine surgery |
Scientific Title of Study
|
Comparison of perioperative analgesic efficacy , haemodynamics and surgeons’ satisfaction between general anaesthesia with erector spinae plane block along with spinal anaesthesia in lumbar spine surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
MD AZIZ BILLAHA |
Designation |
JUNIOR RESIDENT |
Affiliation |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
Address |
Department of Anaesthesiology
Neurosurgery Operation Theatre
Trauma Building , 2nd floor
R. G. KAR MEDICAL COLLEGE AND HOSPITAL
1, Kshudiram Bose Sarani, Kolkata – 700004
1, Kshudiram Bose Sarani, Kolkata – 700004 Kolkata WEST BENGAL 700004 India |
Phone |
8583841295 |
Fax |
|
Email |
azizbillaha@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Saikat Niyogi |
Designation |
Professor |
Affiliation |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
Address |
Department of Anaesthesiology
Neurosurgery operation theatre
Trauma Building, 2nd floor
R. G. KAR MEDICAL COLLEGE AND HOSPITAL
1, Kshudiram Bose Sarani, Kolkata – 700004
1, Kshudiram Bose Sarani, Kolkata – 700004 Kolkata WEST BENGAL 700004 India |
Phone |
9831732443 |
Fax |
|
Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person Public Query
|
Name |
MD AZIZ BILLAHA |
Designation |
JUNIOR RESIDENT |
Affiliation |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
Address |
Department of Anaesthesiology
Neurosurgery Operation Theatre
Trauma Building , 2nd floor
R. G. KAR MEDICAL COLLEGE AND HOSPITAL
1, Kshudiram Bose Sarani, Kolkata – 700004
1, Kshudiram Bose Sarani, Kolkata – 700004 Kolkata WEST BENGAL 700066 India |
Phone |
8583841295 |
Fax |
|
Email |
azizbillaha@gmail.com |
|
Source of Monetary or Material Support
|
GOVERNMENT MEDICAL COLLEGE |
|
Primary Sponsor
|
Name |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
Address |
1, Kshudiram Bose Sarani, Kolkata – 700004 |
Type of Sponsor |
Government 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 |
MD AZIZ BILLAHA |
R .G. Kar Medical College And Hospital |
Department of Anaesthesiology
Neurosurgery Operation Theatre
Trauma Building , 2nd floor
1, Kshudiram Bose Sarani, Kolkata – 700004
Kolkata WEST BENGAL |
8583841295
azizbillaha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
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 |
Erector spinae plane block with Bupivacaine and Fentanyl |
A single administration of 20 ml study drug preparation [bupivacaine (0.25%) 19 ml + fentanyl 1 ml (50 mcg) ] into the target plane between the erector spinae muscles and the transverse process in each side 30 minutes before operation |
Intervention |
Intratheacal Bupivacaine heavy with Fentanyl |
A single administration of subarachnoid block with 15mg bupivacaine heavy with 25 mcg fentanyl prior to operation |
Comparator Agent |
Nil |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Posted for one or two level lumbar discectomy/laminectomy ( L3 , L4 , L5)
2. ASA Grade 1 and 2 patients
3. Age between 18-60 years of either sex
4. Patients with BMI between 20-30
|
|
ExclusionCriteria |
Details |
1.Uncooperative patients or refusal.
2. ASA Grade 3 or above
3. Duration of surgery more than 2 hours
4. Cardiac and neurological diseases.
5. Uncontrolled Diabetes and Hypertension.
6. Chronic Obstructive Pulmonary Disease and Bronchial Asthma.
7. Bleeding disorder
8. On psychiatric medication.
9. Known allergy to the drug used.
10. Epilepsy.
11. Any kind of preexisting neuropathy.
12. Alcoholism.
13. Chronic opioid use (Defined as daily and almost daily use of opioids for more than 3 months).
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1) Duration of analgesia in both groups in terms of VAS score
2) Total analgesic requirement in first 24 hours in both group
|
duration of analgesia is defined as time interval between complete sensory block and time of first rescue analgesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
Intraoperative surgeons satisfaction in terms of 5point Likert scale |
It will be assessed immediately after completion of operation , preferably after 2 hours from start of operation |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
17/07/2023 |
Date of Study Completion (India) |
06/03/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was a randomized single blinded
interventional study and conducted in R.G Kar Medical College and Hospital,
Kolkata with the primary objective of comparing
the duration of analgesia in between GES (General anesthesia with ESPB)
and SA group in terms of first dose of rescue analgesia and, secondary
objective of observing perioperative hemodynamic changes, intraoperative blood
loss , surgeons’ satisfaction and postoperative nausea, vomiting in between these two groups. The
study was done on a total 80 patients divided in two groups( 40 patients in each group) in a span
of one year.
ASA I & II patients and patients not having any
major co-morbidity were included in the study. They were explained the process
well & valid consent was taken . After all routine investigations, pre
anesesthetic check up and overnight fasting GES group were administered bilateral USG guided ESPB
followed by GA and SA group were administered spinal anesthesia in sitting
position.
Intra-operative vitals (HR, SBP, DBP,
MAP , SPO2) were recorded every 15 minutes interval. VAS score for pain along with haemodynamic parameters were
assessed at 1hr, 2 hr, 4 hr, 6 hr, 12 hr and 24 hr.postoperatively. All the patients were instructed to inform when VAS
score for pain > 4 then
rescue analgesia given with IV Tramadol
at a dose of 2mg/kg which were repeated every 6 hours until pain score becomes <
2. Over
the next 24 hr, PONV was also monitored. If nausea scores were greater than 50, antiemetic
therapy with Inj Ondansetron 4 mg IV was
administered which
was repeated every 8 hours , if necessary , until vomiting ceased or nausea
scores decreased to less than 20. Surgeon’s
satisfaction using 5 point Likert scale
and Blood loss using Boezzart’s scale were recorded after completion of surgery
This study has
shown that GA with ultrasound guided ESPB can provide prolong analgesia and
less analgesic requirement in first 24 hours
post operative period in comparison to SA. It also shows us that there was
better surgeons’ satisfaction in GES group than SA group. But there is more
blood loss in GES group. Whereas there was no difference in terms of
perioperative hemodynamic changes and PONV. |