| CTRI Number |
CTRI/2024/03/064519 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does adding Dexamethasone as painkiller prolongs the pain relief after lower back surgery? |
|
Scientific Title of Study
|
The Analgesic Efficacy of Dexamethasone as an adjuvant to Levobupivacaine for Ultrasound Guided Bilateral Erector Spinae Plane Block in Thoraco-lumbar spine surgeries : A Randomized 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 Sutrishna Nag |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology,
AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, 462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
8778657620 |
| Fax |
|
| Email |
sutrrishnan.jr2023@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Head of Department |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology,
AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, 462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Head of Department |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology,
AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, 462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS BHOPAL , non funded |
|
|
Primary Sponsor
|
| Name |
Dr Vaishali Waindeskar |
| Address |
Department of Anesthesiology,
AIIMS Bhopal,
Saket Nagar,
Bhopal. |
| Type of Sponsor |
Research institution |
|
|
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 Sutrishna |
AIIMS Bhopal |
Operation Theatre, Department of Anaesthesiology
Bhopal
MADHYA PRADESH |
8778657620
sutrishnanag502@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHOPAL,Institutional Human Ethics Committee - Student Research (IHEC-SR) |
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 |
Dexamethasone as an adjuvant to Levobupivacaine for Ultrasound Guided Bilateral Erector Spinae Plane Block |
A portable ultrasound machine (Sonosite Fujifilm TM M-Turbo) and Peripheral Nerve Block needle 21G, 100 mm (Pajunk/B-Braun), available in our department will be used. All patients will be turned to prone position after induction of general anesthesia following which the block will be performed at the desired level, i.e. the operative level identified by the surgeons under C-Arm guidance. A linear (6-13 MHz) or a curvilinear (4-7 MHz) ultrasound probe will be used depending on the depth of the transverse process of the patient. The probe will be moved laterally from midline until the desired transverse process is identified. Under aseptic precautions, a 100 mm 21 G insulated peripheral nerve block needle will be inserted parallel to the USG beam (in-line approach) until the tip has contacted the desired transverse process. Once the transverse process is contacted, the needle will be withdrawn a few millimetres, and 0.5-1 ml of isotonic saline will be injected to ascertain the correct plane, following which 20 ml of prepared drug will be injected between the transverse process and erector spinae muscle. The same procedure will be performed at the contralateral side. After 15 -20 minutes of block setup time, the surgeons will be allowed to proceed with the surgical procedure.
|
| Comparator Agent |
Normal saline, 0.9% as an adjuvant to Levobupivacaine for Ultrasound Guided Bilateral Erector Spinae Plane Block |
A portable ultrasound machine (Sonosite Fujifilm TM M-Turbo) and Peripheral Nerve Block needle 21G, 100 mm (Pajunk/B-Braun), available in our department will be used. All patients will be turned to prone position after induction of general anesthesia following which the block will be performed at the desired level, i.e. the operative level identified by the surgeons under C-Arm guidance. A linear (6-13 MHz) or a curvilinear (4-7 MHz) ultrasound probe will be used depending on the depth of the transverse process of the patient. The probe will be moved laterally from midline until the desired transverse process is identified. Under aseptic precautions, a 100 mm 21 G insulated peripheral nerve block needle will be inserted parallel to the USG beam (in-line approach) until the tip has contacted the desired transverse process. Once the transverse process is contacted, the needle will be withdrawn a few millimetres, and 0.5-1 ml of isotonic saline will be injected to ascertain the correct plane, following which 20 ml of prepared drug will be injected between the transverse process and erector spinae muscle. The same procedure will be performed at the contralateral side. After 15 -20 minutes of block setup time, the surgeons will be allowed to proceed with the surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II, scheduled for single/double level thoracolumbar spine surgeries
|
|
| ExclusionCriteria |
| Details |
Minimally invasive surgeries
Patient’s refusal to the block procedure
Contradictions to regional technique e.g., allergy to local anesthetic drugs, block site infection, coagulation disorders.
greater Body mass index of more than thirty five kilogram per meter square
Pregnancy
Physical or mental disorders that would interfere with the evaluation of pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Score (VAS) at 1, 2, 6, 12, 24 and 48 hours at rest (supine position) and during activity (defined as changing position from supine to sitting). |
Visual Analogue Score (VAS) at 1, 2, 6, 12, 24 and 48 hours at rest (supine position) and during activity (defined as changing position from supine to sitting). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total postoperative diclofenac consumption till 48 hours.
Total opioid consumption.
|
till 48 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/03/2024 |
| 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="6"
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
|
Patients undergoing thoracolumbar spine surgeries usually suffer severe
pain during the perioperative period. Fascial
plane blocks are emerging techniques in the management of pain both during the
perioperative period and in the chronic pain. One
among them is the Erector Spinae Plane Block (ESPB).Dexamethasone is added as an adjuvant to levobupivacaine in this study because it has
been reported to prolong duration of action of local anesthetics with no
respiratory depression or any adverse side effects. The aim of this study is to evaluate the
efficacy of combining Dexamethasone to 0.25% Levobupivacaine in ultrasound
guided bilateral Erector Spinae Plane Block in Thoraco-lumbar spine surgeries. Written informed consent will be taken and thorough preanesthetic evaluation will be done to ensure adherence to inclusion and exclusion criteria . A standard general anesthesia technique will be followed in all patients. After turning to prone position, ESPB will be performed under ultrasound guided technique under strict aseptic precautions. After 15 -20
minutes of block setup time, the surgeons will be allowed to proceed with the
surgical procedure and the block success will be assessed with the primary and secondary outcomes.
|