| CTRI Number |
CTRI/2025/11/097602 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of spinal anesthesia with a plane block for analgesia in lower back surgeries. |
|
Scientific Title of Study
|
Comparison of spinal anaesthesia with erector spinae block for analgesia in lumbar spine surgeries - a prospective randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavna sriramka |
| Designation |
professor |
| Affiliation |
IMS and sum hospital |
| Address |
anesthesia department
ims and sum hospital
bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9406033609 |
| Fax |
|
| Email |
bhavna.sriramka@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bhavna sriramka |
| Designation |
professor |
| Affiliation |
IMS and sum hospital |
| Address |
anesthesia department
ims and sum hospital
bhubaneswar
ORISSA 751019 India |
| Phone |
9406033609 |
| Fax |
|
| Email |
bhavna.sriramka@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bhavna sriramka |
| Designation |
professor |
| Affiliation |
IMS and sum hospital |
| Address |
anesthesia department
ims and sum hospital
bhubaneswar
ORISSA 751019 India |
| Phone |
9406033609 |
| Fax |
|
| Email |
bhavna.sriramka@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM Hospital
bhubaneswar, ODISHA,India
751003 |
|
|
Primary Sponsor
|
| Name |
IMS and SUM hospital |
| Address |
Anesthesia department First floor Bhubaneswar 751003 Khordha ORISSA |
| 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 Bhavna sriramka |
IMS and SUM Hospital |
NEUROSURGERY OPERATION THEATRE,First floor,IMS and sum hospital Bhubaneswar 751003 Khordha Khordha ORISSA |
9406033609
bhavna.sriramka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics Commitee, IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: M489||Spondylopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
erector spinae block
|
before GA patient will receive erector spinae block at L2 level Ropivacaine (0.2%) 20 ml and Dexmedetomidine 0.25mcg/kg both sides.
|
| Intervention |
thoracic segmental spinal |
Before GA, the Patient will receive segmental spinal at L1 - L2 isobaric ropivacaine (0.2%) 1.5 ml and dexmedetomidine 5 mcg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Lumbar Surgeries like lumbar discectomy, laminectomy, spinal fusion, or other lumbar spine surgeries, ASA grade (1,2), informed consent |
|
| ExclusionCriteria |
| Details |
cardiovascular diseases, ASA 3 or more then 3
|
|
|
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 |
Compare postoperative pain scores (NRS) after 30 minutes of extubation.
Total analgesic requirement that is number of rescue analgesic doses in 24 hours (tramadol 2 mg/kg) between the two groups
|
30 minutes, 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first analgesic request postoperatively.
Haemodynamic monitoring intra-operatively (HR and MBP )
Evaluate the incidence of intraoperative and postoperative complications, |
baseline, after, Before incision, after skin incision, 15 min, 30 min, 45 min, at the end of extubation.
|
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A significant proportion of people suffer from degenerative disc disease and lumbar disc herniation.The introduction of ultrasound technology into peripheral blocks increased the popularity of plane blocks, particularly the erector spinae plane block (ESPB). Erector spinae plane block (ESPB) is a regional anaesthetic technique in which local anaesthetic spread along the dorsal rami, making this technique specifically appealing for spine surgery. ESPB is usually used for postoperative rescue strategy for pain. Spinal anesthesia is a feasible, safe and economical anesthesia technique for various abdominal and thoracic surgeries. It is also associated with less postoperative complications and patient satisfaction. spinal anesthesia for surgical analgesia in these procedures has been established as an accepted technique for many years. Anesthesia levels for lumbar surgery can be easily achieved with hyperbaric or isobaric local anaesthetics. Some of the benefits of performing spinal anesthesia for lumbar surgery include a perceived decrease in blood loss, lower rates of thromboembolism, less hypertension or tachycardia, and better postoperative pain control. However, most commonly GA is the more preferred technique. This preference may be due to the greater acceptance by patients, the ability to perform longer operations or the anesthesiologist feeling more comfortable seeing that the airway is secured before placing the patient in the prone position. We aim to compare the postoperative pain score with spinal anesthesia in addition to GA with ESPB in patients undergoing lumbar surgeries. |