| CTRI Number |
CTRI/2023/04/051720 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare pain relief after blocking nerves of legs by 2 types of nerve block |
|
Scientific Title of Study
|
Comparative evaluation of Sciatic Obturator Femoral Nerve Block Technique (S.O.F.T Block) versus Central neuraxial blockade for anaesthesia and post operative analgesia for below knee orthopaedic trauma surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1290-5551 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karanbir Singh |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Teerthanker Mahaveer Medical College & RC |
| Address |
Room No 204 Second floor Department of Anesthesia National
Highway 24 Delhi Rd Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7000486410 |
| Fax |
|
| Email |
karankataria36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karanbir Singh |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Teerthanker Mahaveer Medical College & RC |
| Address |
Room No 204 Second floor Department of Anesthesia National
Highway 24 Delhi Rd Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7000486410 |
| Fax |
|
| Email |
karankataria36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Jain |
| Designation |
Associate Professor |
| Affiliation |
Teerthanker Mahaveer Medical College & RC |
| Address |
Room No 204 Second floor Department of Anesthesia National
Highway 24 Delhi Rd Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9855567933 |
| Fax |
|
| Email |
payalravi1408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College & Research Centre Moradabad Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College & Research Centre Moradabad Uttar Pradesh |
| Address |
Department of Anaesthesia , National Highway 24, Delhi Rd,
Bagadpur Uttar Pradesh |
| 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 Karanbir Singh |
Teerthanker Mahaveer Medical College & Research Centre |
Department of Anesthesia , Teerthanker Mahaveer Medical College & Research Centre ,
National Highway 24 Delhi Road Bagadpur
Moradabad
UTTAR PRADESH |
7000486410
karankataria36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S829||Unspecified fracture of lower leg, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Sciatic Obturator Femoral Nerve
Block Technique (S.O.F.T
Block) |
S.O.F.T Block (Sciatic Obturator
Femoral Nerve) Ultrasound
Guided. To block the Femoral
nerve, 15mL of bupivacaine
0.25% will be injected. To block
the obturator nerve, 10mL of
bupivacaine 0.25% will be
injected . To block the sciatic
nerve, 20mL of bupivacaine
0.25% will be injected .Duration to perform S.O.F.T Block is 15 to 20 mins |
| Comparator Agent |
Spinal Anesthesia |
Spinal Anesthesia will be given
with hyperbaric bupivacaine
0.5% (15 mg).Duration to perform Spinal anesthesia is 5 to 7 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent .
ASA physical status I-II
Body mass index 18.5-24.9 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients undergoing bilateral surgery.
Contraindications to regional anesthesia.
Patients with unstable vital signs and patients with head or chest trauma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Visual Analogue Score
2 Hemodynamics
3 Sensory characteristics
4 Motor characteristics |
VAS Score 0,15, 30 minutes
1, 3, 6, 12, 18 hours
Hemodynamics monitored 2, 4, 6, 8, 10, 12, 15,
20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80,
85, 90 minutes, till completion of surgery.
Sensory characteristics every 2 minutes interval
till the establishment of the block and every 5
mins till surgery.
Motor characteristics at every 2 mins till the
achievement of Bromage score 3
,then at the end of surgery and then at 15-min
intervals till( Bromage Score-0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nausea, vomiting , rash , pruritis , seizures and
other complications. |
for first 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
28/04/2023 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After approval from institutional ethical committee, patients will be identified undergoing below knee
orthopedic trauma surgeries and participant will be recruited as per inclusion and exclusion criteria.
Randomization will be done using chit & box method & two groups both including 35 patients will be
created (Group-T & Group-S)
1. Group T- Central Neuraxial Block with hyperbaric bupivacaine 0.5% (15 mg).
2. Group S- S.O.F.T Block guided by Ultrasound .
To block the Femoral nerve, 15mL of bupivacaine 0.25% will be injected.
To block the obturator nerve, 10mL of bupivacaine 0.25% will be injected .
To block the sciatic nerve, 20mL of bupivacaine 0.25% will be injected .
Patients will be preloaded with RL solution at the rate of 10 ml/kg within 15 to 20 mins before
surgery.
After successfully performing the block in both the groups, Hemodynamics (HR, RR, SBP, DBP,
MAP, SP02) vitals will be monitored every 2 mins up to 15mins and thereafter every 5 mins until the
completion of surgery.
Post OP vitals will be monitored at 1, 2, 6, 12, 24, 48 hrs. Sensory block will be tested every 2
minutes interval till the establishment of the block and every 5 mins during the surgery.
In the recovery room , testing has to be conducted every 10 min until the point of two segment
regression of block. Duration of analgesia will be assessed from the onset of sensory block to first
request for rescue analgesia (Visual analog score >4). Pain will be assessed at 1, 3, 6, 12, 18, 24
hrs.
Motor block will be assessed using a modified Bromage scale at every 2 mins till the achievement
of Bromage score 3
Motor block will be assessed and graded at the end of surgery and then at 15-min intervals using
the modified Bromage scale, until full return of lower extremity motor function (Score-0) will be
noted and the patients will be given 15mg/kg Paracetamol for post operative pain, Injection
Tramadol 2 mg/kg IV will be given as rescue analgesia (if VAS >4).
The patients will be observed for first 24 hours for nausea, vomiting, rash, pruritis, seizures and
other complications.
|