| CTRI Number |
CTRI/2023/10/058539 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of pain relief after giving local anaesthesia in two different approaches for patient positioning before spinal anaesthesia in thigh bone fractures |
|
Scientific Title of Study
|
Comparative study of ultra sound(USG) guided fascia iliaca block and quadratus lumborum block for patient positioning prior to spinal anaesthesia in proximal femur fracture surgeries: A prospective randomised comparative 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 |
B Sarath Chandra |
| Designation |
Junior Resident |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074
Bangalore KARNATAKA 560074 India |
| Phone |
9491935823 |
| Fax |
|
| Email |
sarathchandra567@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shankar K |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074
Bangalore KARNATAKA 560074 India |
| Phone |
8971719523 |
| Fax |
|
| Email |
shankarkraj111@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sowmya M J |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074
Bangalore KARNATAKA 560074 India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari medical college and hospital Kambipura Mysore Road Bangalore Karnataka 560074
|
|
|
Primary Sponsor
|
| Name |
Rajarajeshwari medical college and hospital |
| Address |
Kambipura Mysore Road Bangalore Karnataka 560074 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| B SARATH CHANDRA |
Rajarajeshwari medical college and hospital |
2nd floor Department of Anaesthesia Kambipura Mysore road Bangalore Karnataka 560074 Bangalore KARNATAKA |
9491935823
sarathchandra567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascia iliaca block |
Group A will receive Fascia ilia a block before spinal anaesthesia. In Group A, with patient in supine position, with limb kept in resting position, the suprainguinal anatomy will be ascertained with probe placement in the suprainguinal region. Using high frequency linear probe (7 – 15 Hz), the fascia iliaca compartment is approached below as well as above the inguinal ligament. The femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca will be identified. If the division of the femoral artery visualized, the probe will be moved more cranially. In plane technique is used for needle insertion. The needle is advanced until the tip is placed underneath the fascia iliaca (appreciating the pop sensation as the fascia perforates) and negative aspiration will be confirmed, then 25 mL of 0.25% of bupivacaine will be injected. Total duration of intervention is 10minutes. |
| Comparator Agent |
Quadratus lumborum block |
In group-B, patient will be kept in supine position, moved to edge of the bed and a small bolster kept under the buttock, so that the affected side will be easily accessed for placement of probe and needle insertion. 25ml of 0.25% of bupivacaine will be administerd in the lateral aspect of the quadratus lumborum muscle placing the high frequency linear transducer (7 – 15 Hz) on the midaxillary line, between the 12th rib and the iliac crest, the abdominal muscles (external oblique, internal oblique and transversus abdominis) are identified, and the quadratus lumborum muscle, posterior to them. The needle will be inserted in plane approach so as to place the tip anterolateral to the border of quadratus lumborum muscle and local anaesthetic solution will be injected after negative aspiration for blood. Total duration of intervention 10minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with normal BMI aged 18-80years of either gender with American Society of Anaesthesiologists (ASA) I, IIand III status undergoing proximal femur fracture surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient who could sit comfortably
Patient refusing to participate in the study
If drug fail to act
ASA IV
Local anaesthetic allergy
Coagulopathy
Infection at the site of block,
Neuroâ€psychiatric disorders
Pregnant or lactating mothers.
Peripheral neuropathy
Poly trauma patients
Femoral graft in the affected limb
Patients with head injury and peripheral vascular disease.
BMI >30 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the analgesic efficacy of pre operative USG-guided fascia iliaca block & Quadratus Lumborum block for patient positioning prior to spinal anaesthesia in proximal femur fracture surgeries |
VAS score 20min after block & during positioning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative & postoperative analgesic requirement for 24hours, duration of postoperative analgesia, time for mobility in both the groups
Comparison of haemodynamic parameters
Complications if any |
Intraoperative & postoperative VAS score for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
16/10/2023 |
| 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="6" 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
|
Proximal femur fracture surgeries are painful in preoperative period and is associated with morbidity especially in the elderly, due to underlying osteoporosis and presence of other coexisting diseases. Subarachnoid block is the choice of anaesthesia for fracture femur surgeries, but pain can interfere with optimal positioning for administration of spinal anaesthesia. Current methods of providing pre-and post-operative analgesia include non-steroidal anti-inflammatory drugs (NSAIDS), oral or parenteral opioids, and regional anaesthesia techniques.Hence, present study is designed to compare the efficacy of Fascia iliaca block with quadratus lumborum block for positioning and for post-operative analgesia in patients with proximal femur fractures. Aim is to assess the analgesic efficacy of pre operative ultra sound( USG)guided fascia iliaca block and Quadratus Lumborum block for patient positioning prior to spinal anaesthesia in proximal femur fracture surgeries. After approval from institution ethical committee and written informed consent from all patients, this prospective randomised comparative study will be done on 50 patients with normal BMI aged 18-80years of either gender with American Society of Anaesthesiologists (ASA) I, II and III status undergoing proximal femur fracture surgeries under spinal anaesthesia. Simple randomisation will be done by computer generated random numbers and group allocation will be done by sealed envelope technique. Group A will receive USG - guided Fascia iliaca block using 25ml of injection 0.25 % of bupivacaine on ipsilateral side. Group B receive USG - guided Quadratus lumborum block using 25ml of injection 0.25% of bupivacaine on ipsilateral side. Hemodynamics (heart rate, blood pressure, SpO2) will be continuously monitored and recorded every 5minutes till the end of surgery. Post operative pain scores and analgesic consumption will be recorded for first 24hours. IV Paracetamol 1gm will be used as rescue analgesic. |