| CTRI Number |
CTRI/2020/06/025661 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of dexamethasone as an additive agent in erector spinae block for pain relief in patients undergoing back pain surgery: A randomized clinical trial |
|
Scientific Title of Study
|
Role of dexamethasone in erector spinae block in patients undergoing diskectomies: A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitasha Mishra |
| Designation |
assistant professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
department of anesthesia, pain and critical care, room no 7, 5th floor, hospital building, AIIMS, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08373938016 |
| Fax |
|
| Email |
nitsmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitasha Mishra |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
DEPARTMENT OF ANESTHESIA, PAIN AND CRITICAL CARE, room no 7, 5th floor, hospital building, AIIMS, Sijua, Patrapada, Bhubaneswar
c43, cosmopolis apartments, bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08373938016 |
| Fax |
|
| Email |
nitsmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitasha Mishra |
| Designation |
assistant professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of anesthesia, critical care and pain, room no 7, 5th floor, hospital building, AIIMS, Sijua, Patarapada, Bhubaneswar
c43, cosmopolis apartments, bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08373938016 |
| Fax |
|
| Email |
nitsmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIA , AIIMS, BHUBANESWAR |
|
|
Primary Sponsor
|
| Name |
department of anesthesia AIIMS BBSR |
| Address |
department of anesthesia, AIIMS, Bhubaneswar |
| 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 |
| NITASHA MISHRA |
AIIMS, BHUBANESWAR |
DEPARTMENT OF ANESTHESIA, PAIN AND CRITICAL CARE, AIIMS, SIJUA , PATRAPADA, BHUBANESWAR
Khordha
ORISSA |
8373938016
nitsmishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE( IEC) AIIMS, BBSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXAMETHASONE 8MG |
DEXMATHASONE WILL BE GIVEN AS ADJUVANT TO LOCAL ANESTHETIC IN ONE GROUP VS PLACEBO IN THE OTHER GROUP |
| Intervention |
ERECTOR SPINAE BLOCK |
ERECTOR SPINAE BLOCK IS A INTERFACIAL BLOCK WHERE THE LOCAL ANESTHETIC IS DEPOSITED BENEATH THE ERECTOR SPIANE MUSCLE, ITS USUALY GIVEN FOR POST OPEARTIVE PAIN IN ABDOMINAL AND THORACIC SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients age: 18-65 years, American Society of Anesthesiologists 1 or 2 classifications undergoing single or two levels lumbar/ thoracic diskectomy surgery will be enrolled under this study. |
|
| ExclusionCriteria |
| Details |
1) Refusal to consent
2) Infection at the infiltration site
3) Any history of allergy to local anesthetics
4) Failed back surgery syndromes
5) History of chronic pain, narcotic abuse or alcohol dependence.
6) Opioid use in the last 24 hours before surgery.
|
|
|
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 |
Primary outcome :
Time to first rescue analgesia or time at which first rescue analgesia was provided based on VAS ≥4
|
POST OPERATIVE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue score at 1hr, 2hr, 4hr, 6hr and 24h after surgery at rest and movement, incidence of post- operative nausea vomiting and time required for mobilisation will be compared between the two groups. |
POST OPERATIVE |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/06/2020 |
| 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="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
ERECTOR SPINAE BLOCK HAS BEEN RECENTLY FOUND TO BE USEFUL FOR POST OPERATIVE PAIN MANGEMENT IN SPINE SURGERY PATIENST. THROUGH THIS STUDY WE PLAN TO EVELAUTE THE ROLE OF DEXAMETHASONE AS AN ADUVANT IN SPINE SURGERY |