| CTRI Number |
CTRI/2020/11/029117 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
07/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound Guided Block For Below Knee Surgeries |
|
Scientific Title of Study
|
Ultrasound Guided Popliteal Sciatic and Adductor Canal Block For Below Knee 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 K Cheran |
| Designation |
Head Of the Department ,Professor |
| Affiliation |
Vinayaka Missions Medical College |
| Address |
Room no:23, Department Of Anaesthesiology,
Vinayaka Missions Medical College ,
Karaikal
Pondicherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443144652 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Bastina Jenoffia |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Medical College |
| Address |
Room no:23, Department Of Anaesthesiology,
Vinayaka Missions Medical College ,
Karaikal
Pondicherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9176472143 |
| Fax |
|
| Email |
jenoffiamichael@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Bastina Jenoffia |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Medical College |
| Address |
Room no:23, Department Of Anaesthesiology,
Vinayaka Missions Medical College ,
Karaikal
Pondicherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9176472143 |
| Fax |
|
| Email |
jenoffiamichael@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Research Foundation, Ariyanur,Salem-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College |
| Address |
Keelakasakudimedu
Karaikal
Pondicherry 609609 |
| 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 K Cheran |
Vinayaka Missions Medical College |
Room No 23,
Department Of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Pondicherry
Karaikal
PONDICHERRY |
9443144652
anscheran.k73@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound Guided Popliteal Sciatic And Adductor Canal Block |
Under ultrasound Guidance Popliteal Sciatic And Adductor Canal Block will be given using 0.125% Bupivacaine for below knee surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1, ASA 2,ASA 3,ASA 4
2.In-Patient undergoing below knee surgeries
|
|
| ExclusionCriteria |
| Details |
1.Patients allergic to local anaesthetic agents, opioids
2.Patients with Neurological deficits
3.Patients not willing or non-co-operative for the procedure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required to ambulate |
Immediately after surgery and every 30 minutes there after |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of motor blockade as judged by modified Bromage scale |
Immediately after surgery and every 15 minutes there after |
| Ease of surgery as determined by the surgeon |
After completion of surgery |
| Post-operative analgesia duration |
Immediately after surgery and every 15 minutes there after till administration of analgesics |
| Patient satisfaction |
After positioning for surgery and end of the surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
23/11/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Spinal anaesthesia remains as an established technique for lower limb surgeries, but it has its own adverse effects in perioperative morbidity. With a good knowledge of dermatomes, myotomes and osteotomes of lower limbs and the use of ultrasound for peri-neural deposition of local anaesthetics, we can overcome the adverse effects of spinal anaesthesia. Neuraxial blocks can be catastrophic due to instability of haemodynamic parameters and coagulopathy. To overcome the adverse effects of other modes of anaesthesia, studies shows, ultrasound guided peripheral nerve blocks can be a safe alternative. This study aims to delineate the sensory and motor block onset time, hemodynamic parameters and duration of post-operative analgesia for below – knee surgery under ultrasound guided combined popliteal sciatic and adductor canal block. 200 patients of either sex coming for elective below knee surgeries will be this study .Patients allergic to local anaesthetic agents, opiods, patients with Neurological deficits, patients not willing or non-co-operative for the procedure are excluded from this study. After obtaining consent ,ultrasound guided popliteal sciatic and adductor canal block will be given. The degree of motor and sensory blockade ,hemodynamic parameters, ease of positioning ,patient comfort will be noted. Post operatively, time required for ambulation and time requirement for the need of analgesics are noted. Incidence of complication if any, and comfort of the surgeon will aso be noted
|