| CTRI Number |
CTRI/2024/02/062635 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of pain management techniques for surgeries of the backbone |
|
Scientific Title of Study
|
Ultrasound guided bilateral erector spinae plane block for lumbar spine surgery: a prospective randomized controlled double blinded 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 |
Shivananda |
| Designation |
Senior Consultant |
| Affiliation |
Department of Anaesthesiology, Manipal Hospital Whitefield |
| Address |
Department of Anaesthesiology, Manipal Hospital Whitefield,
ITPL Main Rd, opposite Prestige Shantiniketan, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
9686585584 |
| Fax |
|
| Email |
shivananda.nv@manipalhospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivananda |
| Designation |
Senior Consultant |
| Affiliation |
Department of Anaesthesiology, Manipal Hospital Whitefield |
| Address |
Department of Anaesthesiology, Manipal Hospital Whitefield,
ITPL Main Rd, opposite Prestige Shantiniketan, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka
KARNATAKA
560066
India |
| Phone |
9686585584 |
| Fax |
|
| Email |
shivananda.nv@manipalhospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Parvathy V Namboothiri |
| Designation |
Student |
| Affiliation |
Department of Anaesthesiology, Manipal Hospital Whitefield |
| Address |
Department of Anaesthesiology, Manipal Hospital Whitefield,
ITPL Main Rd, opposite Prestige Shantiniketan, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
9656263806 |
| Fax |
|
| Email |
parvathyvnamboothiri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Manipal Hospital Whitefield,
ITPL Main Rd, opposite Prestige Shantiniketan, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka 560066 |
|
|
Primary Sponsor
|
| Name |
Manipal Hospital Whitefield |
| Address |
Department of Anaesthesiology, Manipal Hospital Whitefield, ITPL Main Rd, opposite Prestige Shantiniketan, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka 560066 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shivananda |
Manipal Hospital Whitefield |
First floor, Department of Anaesthesiology, Manipal Hospital Whitefield ITPL Main Rd, opposite Prestige Shantiniketan, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA |
9686585584
shivananda.nv@manipalhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals, Bangalore |
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 |
Erector spinae plane block |
Erector spinae plane block is performed with a single injection mixture of 20 mL of 0.2% Ropivacaine with 2 ml of Fentanyl (100 micrograms) and 2 ml of Dexamethasone (8 mg). The total duration of the procedure is expected to be between 15-30 minutes. The total observation period for the patients is 24-hours from the end of surgery. |
| Comparator Agent |
Non Erector spinae plane block group |
Patients are not given Eretor spinae plane block and are treated with standard intraoperative and postoperative opioids (intravenous Fentanyl and intravenous Tramadol)and other analgesics (intravenous Paracetamol and intravenous Ketorolac) without the use of any regional anaesthetic techniques. The total observation period for the patients is 24-hours from the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status 1 - 3 |
|
| ExclusionCriteria |
| Details |
Patients who are allergic to local anaesthetics.
|
|
|
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 |
| 24-hour postoperative pain scores using Numeric Rating Scare (NRS 0 - 10) |
Baseline (0 hour in the postoperative period); 2 hours; 4 hours; 8 hours; 12 hours, 24 hours in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the number of rescue analgesics needed between patients receiving and not receiving Erector spinae plane block for elective lumbar spine surgery under general anaesthesia. |
24 hours after surgery |
| To compare the patients pain control satisfaction between patients receiving and not receiving Erector spinae plane block for elective lumbar spine surgery under general anaesthesia. |
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
23/02/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This single-center, prospective, randomized, double-blinded study will be conducted at Manipal Hospital Whitefield, Bangalore. Seventy four American Society of Anesthesiologists (ASA) physical status I Iland III patients aged between 30 and 70 years undergoing lumbar spine surgery under general anaesthesia will be recruited for the study. A written informed consent will be obtained from all patients enrolled in the study. Eligible patients will be randomized into two groups: 37 patients in the Erector spinae plane (ESP) block group and 37 patients in the non-ESP block group. |