| CTRI Number |
CTRI/2023/03/050243 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relieving capacity of combined femoral and sciatic nerve block with help of ultrasound using dexamethasone(steroid) as an additive to levobupivacaine(local anesthetic) versus levobupivacaine alone in foot and ankle surgeries: A randomized controlled clinical study |
|
Scientific Title of Study
|
Analgesic efficacy of ultrasound-guided combined femoral and sciatic nerve block using dexamethasone as an adjuvant to levobupivacaine versus levobupivacaine alone in foot and ankle surgeries: A randomized double-blind controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| T/IM-NF/T&EM/22/108 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajitesh Sahu |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences, Bhubaneswar |
| Address |
Room No-103, 1st Floor, Academic Block, AIIMS Bhubaneswar,
Sijua,Po-Dumuduma BHUBANESWAR
Sijua,Po-Dumuduma BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
8826727889 |
| Fax |
|
| Email |
sahu.ajitesh84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajitesh Sahu |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences, Bhubaneswar |
| Address |
Room No-103, 1st Floor, Academic Block, AIIMS Bhubaneswar,
Sijua,Po-Dumuduma BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
8826727889 |
| Fax |
|
| Email |
sahu.ajitesh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajitesh Sahu |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences, Bhubaneswar |
| Address |
Room No-103, 1st Floor, Academic Block, AIIMS Bhubaneswar,
Sijua,Po-Dumuduma BHUBANESWAR
Sijua,Po-Dumuduma BHUBANESWAR
ORISSA
751019
India |
| Phone |
8826727889 |
| Fax |
|
| Email |
sahu.ajitesh84@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Sijua, Po- Dumuduma
Bhubaneswar, Dist-Khorda
751019 |
| Type of Sponsor |
Government medical college |
|
|
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 Ajitesh Sahu |
AIIMS Bhubaneswar |
Trauma & Emergency OT, 1st Floor OT complex, Department of Trauma & Emergency, AIIMS Bhubaneswar
Khordha
ORISSA |
8826727889
sahu.ajitesh84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
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: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine (23 ml of 0.5%) and Dexamethasone 8 mg (2 ml) |
Ultrasound-guided Femoral and popliteal sciatic nerve block to be given with a 22G nerve block needle (Stimuplex, B Braun) of 50mm length, using a 6-13 MHz linear probe (The SonoSite EDGE II; SonoSite, Inc. Bothell, WA, USA), via an in-plane approach after visualization of the nerve sheaths. Duration - 20 to 30 minutes |
| Comparator Agent |
Levobupivacaine (23 ml of 0.5%) and Normal saline 0.9% (2 ml) |
Ultrasound-guided Femoral and popliteal sciatic nerve block to be given with a 22G nerve block needle (Stimuplex, B Braun) of 50mm length, using a 6-13 MHz linear probe (The SonoSite EDGE II; SonoSite, Inc. Bothell, WA, USA), via an in-plane approach after visualization of the nerve sheaths. Duration - 20 to 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of trauma scheduled for unilateral foot and ankle surgery
2. Patients with ASA (American Society of Anesthesiologists) grade I-II |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled Diabetes Mellitus
2. Allergy to local anesthetics
3. Coagulopathy
4. Pregnancy
5. Skin infection at the injection site
6. Patients not willing to give consent
7. Haemodynamically unstable patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the duration of analgesia (time to first rescue analgesia)in both the groups |
Within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To determine the onset time and duration of sensory and motor block |
1. Within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary purpose of this study is to estimate the duration of analgesia and effective surgical anesthesia provided by levobupivacaine and combination of levobupivacaine and dexamethasone when used for femoral and sciatic nerve block for foot and ankle surgeries of trauma. The hypothesis is dexamethasone provides a longer duration of analgesia and patient satisfaction when used as an adjuvant to levobupivacaine for ultrasound-guided femoral and sciatic nerve block. |