| CTRI Number |
CTRI/2025/04/085747 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| 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
|
Finding pain relieving dose of Ketamine,when given with 0.375% Ropivacaine for ultrasound guided erector spinae plane block in spinal surgeries for pain relief |
|
Scientific Title of Study
|
Ketamine as an adjuvant to USG guided Erector Spinae Plane Block with Ropivacaine for
Perioperative Analgesia in Lumbar Spinal Surgeries: A Dose-Finding 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 TIYASA PAIN |
| Designation |
DrNB trainee in Neuroanaesthesia |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
185, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9735853424 |
| Fax |
|
| Email |
tiyasa.sept@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kallol Deb |
| Designation |
Senior consultant in Neuroanaesthesia |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
2nd floor, Department of neuroanaesthesia
185, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9830028915 |
| Fax |
|
| Email |
kalloldeb15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TIYASA PAIN |
| Designation |
DrNB trainee in Neuroanaesthesia |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
185, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9735853424 |
| Fax |
|
| Email |
tiyasa.sept@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata 185/ AJC Bose Road ,Kolkata. West Bengal 700017 India |
|
|
Primary Sponsor
|
| Name |
Institute of Neurosciences Kolkata |
| Address |
185, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tiyasa Pain |
Institute of Neurosciences Kolkata |
2nd floor. Department of neuroanaesthesia and critical care. Institute of neurosciences Kolkata 185, Acharya Jagdish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017
Kolkata
WEST BENGAL |
9735853424
tiyasa.sept@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Neurosciences Kolkata ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilateral ESP block with Ketamine at a dose of 0.75mg/kg body weight |
Patients will receive Erector spinae block with 0.375% ropivacaine and ketamine at 0.75mg/kg body weight , combined to total volume of 40 ml ,equally given as 20ml on both sides |
| Intervention |
Bilateral ESP block with Ketamine at a dose of 1.25 mg/kg body weight |
Patients will receive Erector spinae block with 0.375 %ropivacaine and Ketamine 1.25 mg/kg body weight combined to total volume of 40ml ,equally g8ven as 20ml on both sides |
| Intervention |
Bilateral ESP block with Ketamine at a dose of 1mg/kg body weight maximum 50mg |
Patients will receive Erector spinae block with 0.375% ropivacaine and Ketamine 1mg/kg body weight(maximum 50mg) combined total volume of 40ml,equally given as 20ml on both sides |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All lumbo sacral surgeries including instrumentation procedures duration upto 4 hours of ASA grade I and II with BMI less than 24 |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA grade III and IV in scoliosis correction surgeries with intraoperative neuromonitoring and revision spine surgery duration more than 4 hours
Patient with hypersensitivity to any of drugs in use
Patient with congestive heart failure, CAD, chronic kidney disease, hepatic disease, neuropsychiatic disorder, coagulation abnormalities and pulmonary disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to request of rescue analgesic in first 36 hours and assessment of duration of analgesic using VAS score at 0 hour,2 hour ,4 hour ,8 hour ,12 hour ,24 hour ,36 hour |
Time to request of rescue analgesic in first 36 hours and assessment of duration of analgesic using VAS score at 0 hour,2 hour ,4 hour ,8 hour ,12 hour ,24 hour ,36 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total intraoperative & postoperative opioid consumption |
36 hours |
| Intraoperative haemodynamic stability |
10mins
30mins
1hr
1.5hr
2hr
2.5hr
3hr
3.5hr
4 hr |
| Occurrence of post operative nausea & vomiting |
Anytime in first 36 hr |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
10/05/2025 |
| 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) |
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
|
Post operative pain management in spine surgeries is one of the main concerns because of its potential physiological adverse effects. In the era of Enhanced recovery after surgery, regional anesthesia is an effective method . The effectiveness of Erector spinae block has been demonstrated in various surgeries .Ketamine is known to prolong the duration of analgesia in peripheral nerve block without increasing ketamine related adverse effects. Ketamine was used at different doses in various studies but the effects were not as expected. At higher doses perineurally ketamine failed to produce significant analgesia. Therefore the optimal dosage of ketamine is yet to be determined. We designed a double blinded dose finding study to compare the analgesic efficacy of ketamine at three different doses in Erector spinae block when used with ropivacaine in patients planned for lumbar spinal surgeries . |