| CTRI Number |
CTRI/2023/06/054023 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Patient came for foot surgery and we used ankle block using ropivacaine 0.5% in one group and ropinvacaine 0.5% plus dexamethasone in another group |
|
Scientific Title of Study
|
The Effect of Dexamethasone on duration of surgical anesthesia and postoperative analgesia in USG guided ankle block using 0.5% ropivacaine for foot surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Chittora |
| Designation |
Resident |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
OT complex 2nd floor
Department of Anesthesia
Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur,
Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9664489449 |
| Fax |
|
| Email |
adichittora24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Sachdev |
| Designation |
vice chancellor(Mgumst) and professor of Anesthesia |
| Affiliation |
Mahatma Gandhi hospital |
| Address |
OT complex 2nd floor
Department of Anesthesia
Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur,
Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829055666 |
| Fax |
|
| Email |
propresidentmgu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Sachdev |
| Designation |
vice chancellor(Mgumst) and professor of Anesthesia |
| Affiliation |
Mahatma Gandhi hospital |
| Address |
OT complex 2nd floor
Department of Anesthesia
Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur,
Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829055666 |
| Fax |
|
| Email |
propresidentmgu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi hospital
Sitapura jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura,Jaipur,Rajasthan |
| Type of Sponsor |
Private 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 Aditi Chittora |
Mahatma Gandhi hospital |
OT complex 2nd floor
Department of Anesthesia
Mahatma Gandhi hospital
Sitapura jaipur
Jaipur
RAJASTHAN |
9664489449
adichittora24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (2) ICD-10 Condition: S929||Unspecified fracture of foot and toe, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of dexamethasone-0.5% ropivacaine and 0.5% ropivacaine alone for ankle block for surgical Anesthesia for foot surgery under usg guided ankle block |
60 Consenting patients fulfilling inclusion criteria undergoing foot surgeries under USG guided ankle block during the study period (Sept 2022 to march 2024), will be randomly allocated in two groups of 30 patients each using chit in box method as follows:
Group I (Control group) will receive local injection of 18 ml of 0.5%ropivacaine and 2 ml normal saline.
Group II (Test group) will receive local injection of 18 ml of ropivacaine 0.5% and 2 ml (8 mg) dexamethasone
Route of administration: Local infiltration around the nerves
Duration of study: - Sept 2022 to march 2024 |
| Intervention |
Patients will receive usg guided ankle block using 0.5% ropivacaine in one group and 0.5% ropivacaine with dexamethasone in another group |
60 Consenting patients fulfilling inclusion criteria undergoing foot surgeries under USG guided ankle block during the study period (Sept 2022 to march 2024), will be randomly allocated in two groups of 30 patients each using chit in box method as follows:
Group I (Control group) will receive local injection of 18 ml of 0.5%ropivacaine and 2 ml normal saline.
Group II (Test group) will receive local injection of 18 ml of ropivacaine 0.5% and 2 ml (8 mg) dexamethasone
Route of administration: Local infiltration around the nerves
Duration of study: - Sept 2022 to march 2024 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to participate in this study by written and informed consent.
2.Patients scheduled for foot surgeries.
3.Patients of either sex having age 18-65years.
4.Patient with ASA grade I & II
|
|
| ExclusionCriteria |
| Details |
1.Patient’s refusal for peripheral nerve block.
2.Patients allergic to local anesthetic drugs.
3.Patients on opioids and other analgesics for chronic pain.
4.Neurological deficits
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of adjuvant dexamethasone on duration of analgesia in USG guided ankle block using 0.5% ropivacaine. |
The effects will be assessed for 24hrs post procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse rate , Blood pressure , Spo2, Temperature, Respiratory Rate |
The effects will be assessed for 3 hrs post procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Central neuraxial block or spinal anaesthesia remains
an established technique for lower limb surgeries but with considerable
hemodynamic changes few of these challenges which are faced by spinal
anaesthesia block preoperatively are infection at the site of injection,
deformities of the vertebral column, coagulopathy or other bleeding diathesis,
severe hypovolemia or increased intracranial pressure. Ankle block usually
provides sufficient anesthesia for foot surgeries. It is often applied as an
adjuvant to general anesthesia to establish postoperative analgesia but after
evolution of USG guided ankle block it is now used as sole surgical anesthesia
as well as post operative analgesia and success rate has become much higher.
The advantages of ankle block include the capability of controlling acute
surgical pain, quicker patient ambulation, and absence of adverse effects
related to opioids or nonsteroidal anti-inflammatory drugs.
It is often difficult to demarcate the small
nerves around the ankle on static images. Real-time imaging makes their
position and boundaries easier to define; as we can follow their course and see
their location relative to the other landmarks and structures.
|