| CTRI Number |
CTRI/2023/11/060314 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Dexmeditomidine on quality & duration of Spinae Block in Spine Surgeries |
|
Scientific Title of Study
|
Erector Spinae Plane Block: To study the effect of Dexmeditomidine as an adjuvant to 0.375% Ropivacaine on quality & duration of Erector Spinae Plane Block in Lumbar Spine Surgeries, a randomized control trial 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 Milind Pol |
| Designation |
Associate Professor |
| Affiliation |
Pravara Institute of medical Sciences |
| Address |
Department of Anesthesia At Post Loni Bk Tal Rahata
Dist Ahmednagar Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9890157520 |
| Fax |
02422273442 |
| Email |
drpolmilind@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Milind Pol |
| Designation |
Associate Professor |
| Affiliation |
Pravara Institute of medical Sciences |
| Address |
Department of Anesthesia At Post Loni Bk Tal Rahata
Dist Ahmednagar
MAHARASHTRA 413736 India |
| Phone |
9890157520 |
| Fax |
02422273442 |
| Email |
drpolmilind@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Milind Pol |
| Designation |
Associate Professor |
| Affiliation |
Pravara Institute of medical Sciences |
| Address |
Department of Anesthesia At Post Loni Bk Tal Rahata
Dist Ahmednagar
MAHARASHTRA 413736 India |
| Phone |
9890157520 |
| Fax |
02422273442 |
| Email |
drpolmilind@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara Institute of Medical Sciences Loni |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
At Loni Bk Tal Rahata Dist Ahmednagar |
| Type of Sponsor |
Other [Deemed to be University] |
|
|
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 Milind Pol |
Pravara Institute of Medical Sciences |
Deportment Of Anesthesia & Critical Care First Floor New
OT Complex At Loni Bk Tal Rahata
Dist Ahmednagar Ahmadnagar MAHARASHTRA |
9890157520 02422273442 drpolmilind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Pravara Institute of Medical Sciences Deeemed University IEC PIMS-DU Loni |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmeditomidine |
Patients will receive 0.375% Ropivacaine with 1mcg/kg ( 0.01ml/kg) Dexmeditomidine in a total 40 ml for Erector Spinae plane blocks, bilaterally The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours |
| Comparator Agent |
NS |
will receive 40 ml 0.375% Ropivacaine with 0.01ml/kg NS for ESPB, bilaterally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Physical Status : ASA Grade 1-11
Surgeries : Elective one or two level posterior lumbar decompression, discectomies, interbody fusion
|
|
| ExclusionCriteria |
| Details |
Contraindication to regional blocks : coagulopathy & infection at the block site.
History of opioid abuse.
Physical status – more than ASA11.
History of allergy to any trial drugs, such as Local Anaesthetics & NSAIDS.
Any other condition that precluded study inclusion
Patient Refusal
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| observe & evaluate efficacy & duration of analgesia |
The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours, then at 2,3,4,6,8,12,16,20 & 24 hours respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
sedation
Adverse Events
SpO2, respiratory rate & evidence of respiratory distress |
All the patients will be observed for any side effects or complications in the post-operative period for 24 hours & following complications if occurred were noted & treated |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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 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
|
Aims and Objective Primary 1. To observe & evaluate efficacy & duration of analgesia. 2. Total duration of analgesia. Total duration of analgesia will be calculated as requirement of first analgesic dose after the block. Secondary 2. To evaluate the effects of Dexmeditomidine as an adjuvant A) Hemodynamic parameters. B) Sedation. C) Adverse effect, if any. Materials & Methods: Study Type : Prospective Randomized Control Trial study This will be a Prospective randomized control trial done in Department of Anaesthesia in collaboration with Orthopedic department Rural medical college, Loni. In this study we will evaluate the efficacy of Dexmeditomidine as an adjuvant to Ropivacaine in Erector Spinae Plane Block. In this study, patients undergoing posterior lumbar surgeries, will be recruited & randomly divided into two groups, intervention & control. Inclusion criteria Ø Age : 18 yrs & above Ø Physical Status : ASA Grade 1-11 Surgeries : Elective one or two level posterior lumbar decompression, discectomies, interbody fusion Exclusion criteria Contraindication to regional blocks : coagulopathy & infection at the block site. History of opioid abuse. Physical status – more than ASA11. History of allergy to any trial drugs, such as Local Anaesthetics & NSAIDS. Any other condition that precluded study inclusion Patient Refusal Study conduct: All patients will be examined and assessed pre-operatively for anaesthetic fitness with respect to ASA grading I -11 . Routine investigations will be done. Nature of anaesthesia to be given will be explained to the patients and a valid, written consent will be obtained from the patients. Patients will be kept Nil By Mouth for 6 hours before surgery but clear fluids will be allowed up to 2 hours before commencement of anaesthesia.. Group allocation: The patients will be randomly allocated to 1 of the two groups according to the study drug. Simple Random sampling with Lottery Method will be used for allocation. Group I (control): Patient will receive 40 ml 0.375% Ropivacaine with 0.01ml/kg NS for ESPB, bilaterally Group II (Case) : Patients will receive 0.375% Ropivacaine with 1mcg/kg ( 0.01ml/kg) Dexmeditomidine in a total 40 ml for Erector Spinae plane blocks, bilaterally Technique: In the operation room, intravenous infusion with Ringers Lactate will be started, Oxygen given through facemask 3 litter/minute and routine monitoring as SpO2, NIBP and ECG will be applied (Philips MP 50). Before starting the procedure pulse rate, blood pressure, respiratory rate and oxygen saturation will be recorded. Patient will be given general anaesthesia as per institutional protocol. After giving prone position to the patient, Ultrasound guided Erector Spinae Plane Block will be performed bilaterally. Close monitoring of pulse rate and blood pressure will be done throughout the procedure. We considered fall in systolic blood pressure more than 20% of baseline as a hypotension. Similarly fall in heart rate more than 20% of baseline will be considered as bradycardia. The intra operative hemodynamic monitoring is done at an interval of 15 minutes. Requirement of opioids & top up doses of neuromuscular blocking drugs, are noted. The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours, then at 2,3,4,6,8,12,16,20 & 24 hours respectively with Visual Analog Score ( VAS) pain scores, after surgery, at rest & with movement. Other end points included will be Opioid consumption, other analgesic preparations required. |