| CTRI Number |
CTRI/2020/12/030090 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound-guided combined Sciatic-Femoral nerve block for below knee surgeries. |
|
Scientific Title of Study
|
A Prospective comparative Study between USG Guided Combined Sciatic-Femoral nerve block Versus spinal anaesthesia for the patients undergoing elective 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 |
sanjukta panigrahi |
| Designation |
senior consultant |
| Affiliation |
Ispat General Hospital,Rourkela ,ODISHA |
| Address |
Dept Of Anaesthesiology and critical care medicine ,Ispat General hospital ,Rourkela
Dept of Anaesthesiology and critical care medicine,IGH ROURKELA SECT-19,PIN-769005,ODISHA
Sundargarh
ORISSA
769005
India |
| Phone |
7008724110 |
| Fax |
|
| Email |
sanjuigh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sanjukta panigrahi |
| Designation |
senior consultant |
| Affiliation |
Dept of Anaesthesiology and critical care medicine Ispat General Hospital,Rourkela ,ODISHA |
| Address |
Dept Of Anaesthesiology and critical care medicine ,Ispat General Hospital,Rourkela,Sect-19
Dept of Anaesthesiolgy and critical care medicine ,Ispat General hospital ,Rourkela
Sundargarh
ORISSA
769005
India |
| Phone |
7008724110 |
| Fax |
|
| Email |
sanjuigh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BIBHUTI PATTAJOSHI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
Dept of Anaesthesiology and critical care medicinre,ISPAT GENERAL HOSPITAL,ROURKELA ,ODISHA |
| Address |
Dept of Anaesthesiolgy and critical care medicine ,Ispat General Hospital,Rourkela
Dept of Anaesthesiology and critical care medicine ,Ispat general hospital Rourkela
Sundargarh
ORISSA
769005
India |
| Phone |
7008550208 |
| Fax |
|
| Email |
bibhuti.pattajoshi39@gmail.com |
|
|
Source of Monetary or Material Support
|
| ISPAT GENERAL HOSPITAL,ROURKELA,SECT-19,ODISHA |
|
|
Primary Sponsor
|
| Name |
Ispat General HospitalRourkelaOdisha |
| Address |
Ispat General Hospital,Rourkela-769005,sector-19,Odisha |
| Type of Sponsor |
Other [Hospital run by Steel authority of india(PSU)] |
|
|
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 |
| SANJUKTA PANIGRAHI |
ISPAT GENERAL HOSPITAL |
DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,IGH,SECT-19,ROURKELA-769005
Sundargarh
ORISSA |
7008724110
sanjuigh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD,IGH |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SUBARACHNOID BLOCK |
2ML OF BUPIVACAINE HEAVY 5% HAS BEEN GIVEN WITN 25G QUINCKES NEEDLE AT L3-L4 SPACE AFTER CLEAR CSF SEEN IN UPRIGHT SITTING POSITION IN MEDIAN APPROACH |
| Intervention |
USG Guided Sciatic femoral nerve block
|
In the USFB, the sciatic and femoral nerve blocks will be achieved using a 25 ml mixture consisting of 10 ml of lignocaine adrenaline , 10 ml of 0.5% bupivacaine and 5ml of saline(10ml for the femoral and 15 ml for the sciatic nerve block) under ultrasound guidance using ultrasound(esaote myonelab)
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex,aged between 16-60 yrs
2.Patients with AMERICAN SOCIETY OF
ANAESTHESIOLOGISTS(ASA) grade I and II
3.Elective below knee surgeries
4.The patients who give informed written consent.
|
|
| ExclusionCriteria |
| Details |
1. Known allergies to local anaesthetics
2. Bleeding disorders
3. Localised infections
4. Neurological disease
5. Anatomical abnormalities of spinal
column
6. Respiratory or cardiac disease
7. BMI>32
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To know the duration of onset of sensory and motor blockade
2.Total duration of sensory and motor blockade.
3.Time of first analgesia requirement. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Variation of hemodynamic parameters.
2.Time to first spontaneous urination.
3.Adverse events if any
4.Patient satisfaction |
6 months |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2021 |
|
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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Usg guided combined sciatic femoral nerve block have been widely used in patients posted for below knee surgeries and for patients with critical co-morbidities who cannot tolerate even the slightest alteration of hemodynamic status.The present randomized study comparing SA and Usg guided combined sciatic femoral nerve block below knee surgery in terms of onset of block,duration of anaesthesia,total requirement of analgesia over 24hours,time for requirement of 1st rescue analgesia,the variation of hemodynamic parameters,the quality of nerve block,bladder function and adverse events if any. Spinal anaesthesia is particularly preferred by patients undergoing lower limb surgery due to the fact that only the desired region undergoes nerve blockade . |