| CTRI Number |
CTRI/2024/02/063235 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| 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
|
A comparative study evaluating the postoperative analgesic efficacy of suprainguinal versus infrainguinal approaches of ultrasound-guided fascia iliaca compartment block as single shot block using 0.25%,30ml ropivacaine in patients undergoing surgery for hip fracture under spinal anesthesia. |
|
Scientific Title of Study
|
A comparison of analgesic efficacy of intravenous versus perineural dexamethasone with 0.25% bupivacaine in ultrasound guided infrainguinal fascia iliaca compartment block in patients undergoing lower limb surgery under spinal anaesthesia. |
| 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 Pooja Mathur |
| Designation |
professor |
| Affiliation |
JLN medical college ajmer |
| Address |
Department of Anaesthesia, JLN Medical College ,Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
drpoojarawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Mathur |
| Designation |
professor |
| Affiliation |
JLN medical college ajmer |
| Address |
Department of Anaesthesia, JLN Medical College , Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
drpoojarawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Singh Devanda |
| Designation |
Post graduate student |
| Affiliation |
JLN medical college ajmer |
| Address |
Department of Anaesthesia, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
ravidevanda101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Jawahar Lal Neharu Medical college kala bagh ajmer rajasthan pin code 305001 |
|
|
Primary Sponsor
|
| Name |
Jawahar Lal Neharu Medical college Ajmer |
| Address |
Jawahar Lal Neharu Medical college Ajmer |
| 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 pooja mathur |
Jawahar Lal Neharu Medical college Ajmer |
Department of Anaesthesia, Jawahar Lal Neharu Medical college Ajmer Rajasthan
Ajmer
RAJASTHAN |
09414003933
drpoojarawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JLN Medical College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (3) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (4) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A COMPARISON OF ANALGESIC EFFICACY OF INTRAVENOUS VERSUS PERINEURAL DEXAMETHASONE WITH 0.25% BUPIVACAINE IN ULTRASOUND GUIDED INFRAINGUINAL FASCIA ILIACA COMPARTMENT BLOCK IN PATIENTS UNDERGOING LOWER LIMB SUGERY UNDER SPINAL ANAESTHESIA |
With due approval from institutional ethical committee, A comparative study evaluating the postoperative analgesic efficacy of suprainguinal fascia iliaca block versus infrainguinal approaches of ultrasound-guided fascia iliaca compartment block as single shot block using 0.25%,30ml ropivacaine in patients undergoing surgery for hip fracture under spinal anesthesia. a prospective, hospital based, double blind, randomized, controlled, study has been planned on 60 adult patients of either sex during the time period from 15/02/2024 to 31/08/2024.
Study participants will be patients coming to orthopedic department planned for lower limb surgeries and posted in the operation theatre in the department of anaesthesiology, Jawaharlal Nehru Medical College, Ajmer requiring fascia iliaca compartment block. A written informed consent will be obtained from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure and perioperative course of anaesthesia.
|
| Intervention |
A COMPARISON OF ANALGESIC EFFICACY OF INTRAVENOUS VERSUS PERINEURAL DEXAMETHASONE WITH 0.25% BUPIVACAINE IN ULTRASOUND GUIDED INFRAINGUINAL FASCIA ILIACA COMPARTMENT BLOCK IN PATIENTS UNDERGOING LOWER LIMB SUGERY UNDER SPINAL ANAESTHESIA |
With due approval from institutional ethical committee,A comparative study evaluating the postoperative analgesic efficacy of suprainguinal fascia iliaca block versus infrainguinal approaches of ultrasound-guided fascia iliaca compartment block using 0.25%,30ml ropivacaine in patients undergoing surgery for hip fracture under spinal anesthesia. a prospective, hospital based, double blind, randomized, controlled, study has been planned on 60 adult patients of either sex during the time period from 15/02/2024 to 31/08/2024.
Study participants will be patients coming to orthopedic department planned for lower limb surgeries and posted in the operation theatre in the department of anaesthesiology, Jawaharlal Nehru Medical College, Ajmer requiring fascia iliaca compartment block. A written informed consent will be obtained from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure and perioperative course of anaesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18years and above.
2. Patients belonging to ASA (American Society of Anaesthesiologists) class-I, II and III
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent to participate in the study.
2. Uncooperative patients.
3. Patient with chronic pain or on long-term analgesics.
4. Any known hypersensitivity or contraindication to bupivacaine or any other local anesthetic.
5. Local pathology at the site of injection or disability limiting the performance of block.
6. Inadequate block necessitating institution of general anaesthesia
for continuation of surgical procedure
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of perineural versus intravenous dexamethasone in prolonging analgesic duration of fascia illiaca compartment block for lower limb orthopedic surgeries. |
Within 24hours after completion of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the duration of sensory block.
2. To assess the duration of motor block.
3. To assess & compare hemodynamic changes if any.
4. Total rescue analgesia consumption in 24 hrs.
|
Within 24hours after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| 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
|
With due approval from institutional ethical committee, a prospective,
hospital based, double blind, randomized, controlled, study has been planned on
60 adult patients of either sex.Study participants will be patients coming to orthopedic department planned for lower limb surgeries and posted in the operation theatre in the department of anaesthesiology, Jawaharlal Nehru Medical College, Ajmer requiring fascia illiaca compartment block. A written informed consent will be obtained from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure and perioperative course of anaesthesia.
|