| CTRI Number |
CTRI/2025/12/098621 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of dexamethasone and ketamine as a supplement to levobupivacaine for pain relieving nerve block technique in lower back surgery. |
|
Scientific Title of Study
|
Efficacy of dexamethasone versus ketamine as adjuvant to 0.25 percentage Levobupivacaine in Ultrasound-guided erector spinae plane block in lumbar fusion surgery- A randomized controlled study. |
| 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 Debasis Kuanar |
| Designation |
Consultant |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology , 3rd floor , Kalinga Institute Of Medical Sciences , Bhubaneswar.
Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
07381056574 |
| Fax |
|
| Email |
dkuanar1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Pradhan |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor , Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9437191002 |
| Fax |
|
| Email |
amitpdear@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alisha Mohanty |
| Designation |
PGT-1 |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology ,3rd floor , Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9668215230 |
| Fax |
|
| Email |
am8576@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute Of Medical Sciences, Bhubaneswar, Khordha, Odisha, PIN 751024 |
|
|
Primary Sponsor
|
| Name |
DrDebasis Kuanar |
| Address |
Department of Anaesthesiology 3rd floor Kalinga Institute Of Medical Sciences Bhubaneswar 751024 Odisha India |
| 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 Debasis Kuanar |
Pradyumna Bal Memorial Hospital, Kalinga Institute Of Medical Sciences |
Department of Anaesthesiology. 3rd floor , Kalinga Institute Of Medical Sciences, Bhubaneswar
Khordha
ORISSA |
07381056574
dkuanar1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee , Kalinga Institute Of Medical Sciences, KIIT deemed to be University, Bhubaneswar-751024 |
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 |
Addition of Dexamethasone as adjuvant to 0.25 percent of Levobupivacaine in Erector spinae block for lumbar fusion surgery |
Group 1: will receive 20 ml of 0.25 percent Levobupivacaine + Dexamethasone 1mg bilaterally in ultrasound guided erector spinae block for a single shot block, as a one time administration before surgery. |
| Comparator Agent |
Addition of Ketamine as adjuvant to 0.25 percent Levobupivacaine in Erector spinae block in lumbar fusion surgery |
Group 2- will receive 20 ml of 0.25 percent Levobupivacaine + Ketamine 50mg bilaterally in ultrasound guided erector spinae block for a single shot block, as a one time administration before surgery. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society Of Anaesthesiologists(ASA) physical status I-III.
2.Patients aged more then 30 years undergoing single level lumbar fusion surgery . |
|
| ExclusionCriteria |
| Details |
1.Allergy to study drugs
2.Coagulopathy
3.Local and systemic infections.
4.Patients with cognitive impairment .
5.BMI more than or equal to 30 kg per m²
6.Lumbar spine injury.
7.Significant hepatic and renal function impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Visual Analog Scale(VAS) pain scores to 0,2,4,8,12,18 and 24 hours post operatively |
0,2,4,8,12,18 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) before incision, 3mins after incision and then every 15 minutes till the end of surgery,
2.Time to first rescue analgesic.
3.Total number of times of requirement of rescue analgesic.
4.Incidence of side effects like respiratory depression, sedation, nausea and vomiting.
|
1.Before incision.
2.3 mins after incision.
3.Every 15 mins after incision. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 |
|
Date of First Enrollment (India)
|
18/12/2025 |
| 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="2"
Months="0"
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
|
The erector spinae plane (ESP) block is a safe and effective technique for postoperative analgesia in Lumbar Fusion Surgery. Dexamethasone, a glucocorticoid acting via C fiber inhibition, or Ketamine which is a NMDA receptor antagonist when added to Levobupivacaine can prolong its analgesic effect. Primary objective: To assess postoperative pain scores over 24 hours in patients undergoing lumbar spine fusion surgery who receive either a combination of levobupivacaine and dexamethasone or ketamine. Secondary Objective: Intraoperative hemodynamic changes , Time of requirement of first rescue analgesic ,total number of times of requirement of rescue analgesic. and its associated side effects. |