| CTRI Number |
CTRI/2024/11/077119 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of single and double adjuvant drugs in nerve block of lower limb surgeries |
|
Scientific Title of Study
|
Comparison Of Perineural Dexamethasone And Dexmedetomedine Vs Dexamethasone Only As An Adjuvant In Ultrasound Guided Sciatic Nerve Block Via Popliteal Approach In Orthopaedic Below Knee Surgeries A Double Blind Randomised 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 Sachin Kumar |
| Designation |
Assistant Professor AIIMS New Delhi |
| Affiliation |
all india institute of medical sciences |
| Address |
Room no 403, 4th Floor Surgical Block Department of Anesthesia, pain medicine & Critical care AIIMS New Delhi Room no 403, 4th Floor Surgical Block Department of Anesthesia, pain medicine & Critical care AIIMS New Delhi South West DELHI 110029 India |
| Phone |
9871549343 |
| Fax |
|
| Email |
sk2007696@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sachin Kumar |
| Designation |
Assistant Professor AIIMS New Delhi |
| Affiliation |
all india institute of medical sciences |
| Address |
Room no 5011 Department of anesthesia , Pain Medicine & Critical Care anesthesia office 5th floor teaching block AIIMS New Delhi
South West DELHI 110029 India |
| Phone |
9871549343 |
| Fax |
|
| Email |
sk2007696@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sachin Kumar |
| Designation |
Assistant Professor AIIMS New Delhi |
| Affiliation |
all india institute of medical sciences |
| Address |
Room no 403, 4th Floor Surgical Block, Department of Anesthesia, Pain Medicine & Critical Care ,AIIMS New Delhi Room no 403, 4th Floor Surgical Block, Department of Anesthesia, Pain Medicine & Critical Care ,AIIMS New Delhi South West DELHI 110029 India |
| Phone |
9871549343 |
| Fax |
|
| Email |
sk2007696@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Sachin kumar AIIMS NEW DELHI |
| Address |
Anesthesia Office 5th floor teaching block MAIN AIIMS , NeW Delhi |
| 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 SACHIN KUMAR |
AIIMS New Delhi |
Room no 403 4th floor Surgical Block All India Institute Of Medical Sciences New Delhi South West DELHI |
9871549343
sk2007696@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dex group |
one agent that is dexamethasone 4 mg will be added to 0.375 % ropivacaine to give popliteal sciatic nerve block |
| Intervention |
dex-dexmed group |
Two agents that is dexamethasone 4mg and dexmeditomedine 20 mcg will be added to 15 ml of 0.375 % ropivacaine to give popliteal sciatic nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Can provide consent
3. Below knee surgeries
4. ASA 1-3 physical status
|
|
| ExclusionCriteria |
| Details |
1. Local site infection
2. Local anaesthetic allergy
3. Pre-existing neurological deficit in lower limb
4. Peripheral vascular disease
5. Bleeding diasthesis/coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia in patients undergoing below knee surgeries under neuraxial blockade after administration of sciatic nerve block without adjunct, with dexamethasone (single adjunct) and with 2 adjuncts (dexamethasone and dexmedetomidine). |
Post operative pain at 30 min., 2hour , 4 hour, 8 hour ,12 hour, 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the opioid requirements in patients undergoing below knee surgeries under neuraxial blockade after administration of sciatic nerve block without adjunct, with dexamethasone (single adjunct) and with 2 adjuncts (dexamethasone and dexmedetomidine).
2. To compare the side effects of sciatic nerve block with no adjunct, single adjunct and 2 adjuncts.
|
at the end of 24 hours after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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 1 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="2" Months="0" 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
|
Postoperative pain after orthopedic lower limb surgery is a very distressing symptom and a major component of the postoperative morbidity.Considering the extensive number of orthopaedic surgeries undertaken every day and finding an opioid sparing and convenient options for analgesia, this study aims to investigate whether the adjuvant combination of dexamethasone and dexmedetomidine could additively provide a longer duration of blockade and superior analgesia compared to using Ropivacaine alone in a peripheral sciatic nerve block performed by the popliteal approach. An ultrasound machine with a high frequency 9-13 MHz linear probe will be used considering the minimal penetration of tissues required. A 22G, 100 mm needle will be used to administer the block. Although approachable by the patient in the supine, lateral, or prone position, in order to minimize patient discomfort, especially when awake, patient is placed in the supine position with the legs elevated with folded blankets or an adjustable table. The skin is prepared with 0.5% chlorhexidine. The transducer is positioned in a transverse orientation at the popliteal fossa. At this level, the popliteal artery is identified and confirmed with colour flow or power doppler. Once the artery is visualized, the hyperechoic nerves are located superficially. To visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally, with the CPN travelling laterally and the TN staying medially, it is traced proximally. The optimal image is the configuration of the nerves just as they begin to separate, giving a peanut or figure 8 shape. . HR, NIBP, SpO2 at 30 mins, 1hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours postoperatively ii. Postoperative pain at rest and on movement as assessed by Numeric Rating Scale at 30mins, 1hour, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively iii. Time to first rescue analgesic is noted in the post operative room as time of administration of morphine via epidural or Intravenous tramadol in case of SAB
|