| CTRI Number |
CTRI/2024/04/065422 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To determine the volume of drug required in fascia iliaca compartment block for pain relief in population of Assam |
|
Scientific Title of Study
|
A study to evaluate 95% effective volume of 0.2% ropivacaine for ultrasound guided suprainguinal fascia iliaca compartment block-a single centre observational study |
| 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 Nur Alom Sheikh |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup
ASSAM
781032
India |
| Phone |
7002178483 |
| Fax |
|
| Email |
drnuralam1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyam Saikia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup
ASSAM
781032
India |
| Phone |
9706067392 |
| Fax |
|
| Email |
saikia.priyam80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyam Saikia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup
ASSAM
781032
India |
| Phone |
9706067392 |
| Fax |
|
| Email |
saikia.priyam80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital
Post Office and Police Station-Bhangagharh
District-Kamrup(Metro)
State-Assam
PIN-781032 |
|
|
Primary Sponsor
|
| Name |
Dr Nur Alom Sheikh |
| Address |
Department of Anaesthesiology and Critical care
Gauhati Medical College and Hospital
Bhangagarh
District-Kamrup(Metro)
State-Assam
PIN-781032 |
| 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 Nur Alom Sheikh |
Gauhati Medical Colllege and Hospital |
Department of Anaesthesiology and Critical Care,GMCH
Kamrup
ASSAM |
7002178483
drnuralam1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Gauhati Medical College & Hospital |
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 |
Injection ropivacaine |
0.2% ropivacaine to be adminstered via USG guided to fascia iliaca compartment for analgesia |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 years to 45 years
2.Patients with BMI 18.5 to 24.9 kg/square meter
3.ASA status 1 and 2
4.Patients posted for elective orthopedic femur fractures and hip surgeries
5.Patient giving informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Patient unable to co-operate
2.Absolute contraindications for use of local anaesthetic agents or use of regional anaesthesia technique
3.Block failure or partial blocks
4.Pregnant and lactating patients
5.Patient with psychiatric diseases
6.Patient using psychoactive substances
7.Patient with impaired hearing
8.Patient using drugs for chronic pain |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate 95% effective volume of 0.2% Ropivacaine for ultrasound guided suprainguinal fascia iliaca compartment block. |
To evaluate 95% effective volume of 0.2% Ropivacaine for ultrasound guided suprainguinal fascia iliaca compartment block in Orthopedic patients within 30 minutes of performing the blocks prior to surgery at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the onset time of sensory block
2.To determine the hemodynamic changes following block
3.To determine the incidence of vessel puncture,haematoma or other intraprocedural complications. |
To determine the onset time of sensory block,hemodynamic changes following block,and any intraprocedural complications in Orthopedic patients within 30 minutes of performing the block prior to surgery at baseline. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
17/04/2024 |
| 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="1"
Months="0"
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
|
Large volume of local anaesthetic is often used to achieve perfect compartment blockeffect that may increase the toxic reaction of local anaesthetics and the incidence of complications.It is safer to use the minimum effective volume of local anaesthetic.In recent years , ultrasound guided peripheral nerve block has become an important part of multimodal analgesia.Studies have shown that the 95% minimum effective volume of suprainguinal fascia ilica compartment block with 0.33% ropivacaine to be 34.06 ml.We commonly use 0.2% ropivacaine for lower limb compartment blocks.Therefore we intended to evaluate the 95% minimum effective volume of 0.2% ropivacaine for ultrasound guided suprainguinal fascia iliaca compartment block in our patient populations. |