| CTRI Number |
CTRI/2024/09/073479 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effect of steroid when added to local anaesthetic drug versus only local anaesthetic in giving Popliteal Sciatic Block using sonography for reducing pain after below knee surgeries |
|
Scientific Title of Study
|
Comparison of dexamethasone as an adjuvant to ropivacaine with ropivacaine alone in usg guided popliteal sciatic block for post operative analgesia in below knee surgeries-a randomized controlled trial |
| 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 Akshay Uttarwar |
| Designation |
junior resident |
| Affiliation |
Lata Mangeshkar Hospital, Hingna, Nagpur |
| Address |
OT complex, department of anesthesiology, lata mangeshkar hospital, hingna, nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
08087079132 |
| Fax |
|
| Email |
auttarwars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Palsodkar |
| Designation |
Associate professor |
| Affiliation |
Lata Mangeshkar hospital, Digdoh hills, Hingna, Nagpur |
| Address |
OT complex, department of anesthesiology, Lata Mangeshkar hospital, Digdoh hills, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9021189372 |
| Fax |
|
| Email |
shanky.waitforit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Akshay Uttarwar |
| Designation |
junior resident |
| Affiliation |
Lata Mangeshkar hospital, Digdoh hills, Hingna, Nagpur |
| Address |
OT complex, department of anesthesiology, lata mangeshkar hospital, digdoh hills, hingna, nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
08087079132 |
| Fax |
|
| Email |
auttarwars@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT complex, department of anesthesiology, lata mangeshkar hospital, digdoh hills, hingna, nagpur. |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Uttarwar |
| Address |
OT complex, department of anesthesiology, lata mangeshkar hospital, digdoh hills, hingna, nagpur, maharashtra, india -440019 |
| Type of Sponsor |
Other [self] |
|
|
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 AKSHAY UTTARWAR |
Lata Mangeshkar Hospital |
OT complex, department of anesthesiology, LATA MANGESHKAR HOSPITAL, DIGDOH HILLS, NAGPUR, maharashtra, india 440019
Nagpur
MAHARASHTRA |
08087079132
auttarwars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL EHICAL COMMITTEE |
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 with ropivacaine |
injection ropivacaine 0.25% 15ml with injection dexamethasone 8mg will be given in popliteal sciatic nerve sheath using sonography for post operative pain relief and patient will be followed up at 1,3,6,12,24 hours |
| Comparator Agent |
ropivacaine only |
injection ropivacaine 0.25% 15ml with normal saline 2ml will be given in popliteal sciatic nerve sheath using sonography for post operative pain relief and patient will be followed up at 1,3,6,12,24 hours |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient scheduled for below knee surgeries under subarachnoid block. Patient giving consent for the study. |
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetic drug. Bleeding disorders. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Dexamethasone as an adjuvant to Ropivacaine and Ropivacaine alone for post operative analgesia in ultrasound guided Popliteal Sciatic nerve block in below knee surgeries with respect to :
Total analgesia requirement in first 24 hours
Numerical Rating Scale (NRS) for pain assessment
Time for requirement of first rescue analgesia
|
Patient will be assessed for pain at 1,3,6,12,24 hours. Requirement of intravenous analgesia in 24 hours will calculated. Time taken for first complain for pain after surgery will be noted.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Dexamethasone as an adjuvant to Ropivacaine & Ropivacaine alone for side effects in ultrasound guided Popliteal Sciatic nerve block in below knee surgeries with respect to : 1) Nausea 2) Vomiting |
Patient will be followed for complain of nausea or vomiting in the first 24 hours after the surgery. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To compare dexamethasone as an adjuvant
to ropivacaine and ropivacaine alone for
post-operative analgesia in ultrasound guided
popliteal sciatic nerve block in below
knee surgeries with respect to :
1) Total analgesia
requirement in first 24 hours
2) Numerical Rating
Scale (NRS) for pain assessment
3) Time for
requirement of first rescue analgesia |