| CTRI Number |
CTRI/2025/12/099716 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between efficacy of erector spinae plane block and retrolaminar block (2 types of injections with local anaesthetics) in providing pain relief after spine surgery |
|
Scientific Title of Study
|
Efficacy of erector spinae plane block versus retrolaminar block for perioperative analgesia following posterior dorso-lumbar spine instrumentation surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Chakrabarti |
| Designation |
Consultant |
| Affiliation |
IPGMER Kolkata |
| Address |
Bangur Institute of Neurosciences, department of Neuroanaesthesia, first floor, 244, AJC Bose Road, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8910129978 |
| Fax |
|
| Email |
drsoumyachakrabarti@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Chakrabarti |
| Designation |
Consultant |
| Affiliation |
IPGMER Kolkata |
| Address |
Bangur Institute of Neurosciences, department of Neuroanaesthesia, first floor, 244, AJC Bose Road, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8910129978 |
| Fax |
|
| Email |
drsoumyachakrabarti@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Chakrabarti |
| Designation |
Consultant |
| Affiliation |
IPGMER Kolkata |
| Address |
Bangur Institute of Neurosciences, department of Neuroanaesthesia, first floor, 244, AJC Bose Road, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8910129978 |
| Fax |
|
| Email |
drsoumyachakrabarti@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| No monetory support. Drugs used and ultrasound machine used will be from the government supply |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Not applicable |
| Type of Sponsor |
Other [None] |
|
|
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 Soumya Chakrabarti |
IPGMER & SSKM Hospital |
Bangur institute of Neurosciences, department of Neuroanaesthesia, first floor, operation theatre
Kolkata
WEST BENGAL |
8910129978
drsoumyachakrabarti@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae plane block |
19 ml of 0.25 % bupivacaine and 1 ml of dexamethasone given bilaterally between erector spinae muscle and transverse process under ultrasound guidance at surgical level over 5 minutes before induction of anaesthesia |
| Intervention |
Retrolaminar block |
19 ml of 0.25 % bupivacaine and 1 ml of dexamethasone given bilaterally between transversospinalis muscles and laminae under ultrasound guidance at surgical levels over 5 minutes before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 – 65 years of age
2. Either gender
3. ASA status I-II
4. Patients undergoing thoracolumbar spine instrumentation surgeries
5. Patients getting extubated at the end of the surgery
6. Patients with intact mentation and speech
|
|
| ExclusionCriteria |
| Details |
1. Surgery duration exceeding 3 hours
2. Patient having any coagulopathy
3. Patient having scar or infection at injection site
4. Patient having any psychiatric disorder, severe cardiac, pulmonary, hepatic or renal insufficiency
5. History of preoperative chronic opioid use, long term drinking or psychotropic drug use
6. Pregnancy and lactation
7. Patients with severe visual and auditory disorders
8. History of allergy or anaphylaxis to any local anesthetic
9. Spine instrumentation not more than 3 vertebral levels
10. Intraoperative alteration of surgery
11. Patients who will withdraw for any reason
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score postoperatively upto 24 hours |
upto 24 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a) first time to postoperative systemic rescue analgesic
(b) perioperative hemodynamics upto 24 hours postoperatively
(c) adverse effects in the two groups
|
from administration of block upto 24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spine instrumentation surgeries involve extensive amount of tissue and bone trauma thus resulting in significant perioperative pain. Effective analgesia involves a multimodal approach combining systemic medications, regional nerve blocks, and patient controlled analgesia. Recently, regional analgesia techniques, such as the erector spinae plane block (ESPB), retrolaminar block (RLB) and thoracolumbar interfascial plane (TLIP) block, are being used. In this study, we will compare the efficacy of ultrasound guided ESPB and RLB in decreasing perioperative pain, the requirement of systemic analgesics and maintaining haemodynamic stability in dorsolumbar spine instrumentation surgeries. This will be a single blinded randomised controlled trial. After randomisation into two groups, we will administer either of ESPB or RLB with 19 ml 0f 0.25 % bupivacaine and 1 ml of dexamethasone bilaterally at a single targeted level approximately half an hour before surgery. We will record haemodynamics at various time points, and postoperative pain scores upto 24 hours. We will also document the requirement of systemic rescue analgesics postoperatively. |