| CTRI Number |
CTRI/2025/03/083314 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| 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 ,changes in pulse rate, blood pressure and surgeon’s satisfaction between landmark guided, C-Arm guided And USG guided erector spinae block in lumbar spine surgery |
|
Scientific Title of Study
|
Evaluation Of landmark guided, C-Arm guided And USG guided erector spinae block in terms of perioperative analgesia, hemodynamics snd surgeon’s satisfaction following lumbar spine fixation surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONALINA MUDI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Neurosurgery OT,Department of Anaesthesia, pain & critical care, Trauma building
1, KHUDIRAM BOSE SARANI , SHYAMBAZAR, KOLKATA - 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9051283086 |
| Fax |
|
| Email |
sonalina.mudi701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SONALINA MUDI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Neurosurgery OT, Department of Anaesthesia, pain & critical care, Trauma building
1, KHUDIRAM BOSE SARANI , SHYAMBAZAR, KOLKATA - 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9051283086 |
| Fax |
|
| Email |
sonalina.mudi701@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SONALINA MUDI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Neurosurgery OT, Department of Anaesthesia, pain & critical care, Trauma building
1, KHUDIRAM BOSE SARANI , SHYAMBAZAR, KOLKATA - 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9051283086 |
| Fax |
|
| Email |
sonalina.mudi701@gmail.com |
|
|
Source of Monetary or Material Support
|
| R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
1, KHUDIRAM BOSE SARANI , SHYAMBAZAR , 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 |
| SONALINA MUDI |
R. G. KAR MEDICAL COLLEGE AND HOSPITAL |
1, KHUDIRAM BOSE SARANI , SHYAMBAZAR , KOLKATA - 700004
NEUROSURGERY OT(2ND FLOOR),TRAUMA BUILDING,DEPARTMENT OF ANAESTHESIA,PAIN AND CRITICAL CARE
Kolkata
WEST BENGAL |
9051283086
sonalina.mudi701@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 |
EVALUATION OF LANDMARK GUIDED, C-ARM GUIDED AND USG GUIDED ERECTOR SPINAE BLOCK IN TERMS OF PERIOPERATIVE ANALGESIA,HEMODYNAMICS AND SURGEON’S SATISFACTION FOLLOWING LUMBER SPINE FIXATION SURGERY |
After getting clearance from the said ethics committee this study will be conducted in the neurosurgery operation theatre of R.G Kar Medical College & Hospital in the period from 2025 to 2026. After careful consideration of inclusion and exclusion criteria the patients posted for lumbar spine fixation surgery will be enrolled in the study. Patients will be divided into three equal groups [landmark guided erector spinae block vs C-ARM guided erector spinae block vs USG guided erector spinae block] by computer-generated randomization method. Every group will receive bilateral erector spinae block using 0.25 % Bupivacaine followed by general anaesthesia. Duration of analgesia in terms of VAS , total analgesic requirement in first 24 hours ,Intraoperative surgeons’ satisfaction in terms 0f 5-point Likert scale, intraoperative blood loss using Boezzarts scale, hemodynamic changes by measuring mean arterial pressure (MAP) and pulse rate and other side effects like post operative nausea , vomiting , patients’ discomfort will be assessed and compared between these three groups.
Landmark guided, C -arm guided and USG guided technique will take time of approximately 10 minutes,20 minutes and 15 minutes respectively |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Posted for lumbar spine fixation surgeries
2. 2 or 3 level lower lumbar spine (L3-L4/L4-L5) surgery by posterior approach
3. ASA Grade 1 and 2 patients
4. Age between 18-60 years of either sex
5. Patients with BMI between20-30
|
|
| 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 |
To compare the duration of post-operative analgesia.(timing of first rescue analgesic)
2) Grade of sensory block through touch and pin prick method.
3) Motor function of leg will be evaluated with a Bromage (0-3) score.
|
JUNE 2023 TO JUNE 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) Intraoperative haemodynamics with respect to changes in HR and MAP.
ii) Intraoperative bleeding using Boezzart’s scale
iii) Intraoperative surgeons’ satisfaction using Likert scale
iv) Postoperative analgesic consumption in first 24 hr
v) Frequency of postoperative analgesic administration.
|
JUNE 2023 TO JUNE 2024 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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 Applicable |
| 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
|
After getting clearance from the said ethics committee
this study will be conducted in the neurosurgery operation theatre of R.G Kar
Medical College & Hospital in the
period from 2022 to 2023. After careful consideration of inclusion and
exclusion criteria the patients posted for lumbar spine fixation surgery will
be enrolled in the study. Patients will be divided into three equal groups [landmark
guided erector spinae block vs C-ARM guided erector spinae block vs USG guided
erector spinae block] by computer-generated randomization method. Every group will receive bilateral erector spinae block using 0.25 %
Bupivacaine followed by general anaesthesia. Duration of analgesia in terms of VAS , total analgesic requirement
in first 24 hours ,Intraoperative
surgeons’ satisfaction in terms 0f 5-point Likert scale, intraoperative blood loss using Boezzart’s
scale, hemodynamic changes by measuring mean arterial pressure (MAP) and
pulse rate and other side effects like post operative nausea , vomiting , patients’
discomfort will be assessed and compared between these three
groups. |