| CTRI Number |
CTRI/2019/03/017975 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
20/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ultrasound guided blocks in relieving post operative pain after hip fracture surgeries |
|
Scientific Title of Study
|
Comparison of ultrasound guided continuous Erector Spinae Plane Block versus continuous Paravertebral block for post operative analgesia in patients undergoing proximal femur surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Mehrotra |
| Designation |
Post Graduate Student |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Critical Care, Ground Floor, Main OT Building, VMMC and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9717268806 |
| Fax |
|
| Email |
adityameh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu Dayal |
| Designation |
Professor and Specialist Grade I |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Critical Care, Ground Floor, Main OT Building, VMMC and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Mehrotra |
| Designation |
Post Graduate Student |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Critical Care, Ground Floor, Main OT Building, VMMC and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9717268806 |
| Fax |
|
| Email |
adityameh@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Department Of Anaesthesiology and Critical Care, Ground Floor, Main OT Building, VMMC and Safdarjung Hospital, New Delhi |
| 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 Aditya Mehrotra |
VMMC And Safdarjung Hospital |
Department Of Anaesthesiology and Critical Care, Ground Floor, Main OT Building, VMMC and Safdarjung Hospital, New Delhi
South
DELHI |
09717268806
adityameh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
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, (2) ICD-10 Condition: S721||Pertrochanteric fracture, (3) ICD-10 Condition: S722||Subtrochanteric fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided Lumbar Erector Spinae Plane block |
Lumbar ESP block will be performed at the beginning of surgery. A linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 2-4 cm lateral to L2 spinous process. The erector spinae muscles will be identified superficial to the tip of L2 transverse process. The patients skin will be anesthetized with 2% lidocaine. A 18-gauge 10-cm Tuohy’s needle will be inserted using an in plane approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. Following this, a 18G catheter is threaded through the Tuohy’s needle. |
| Comparator Agent |
Ultrasound Guided Paravertebral block |
Patient will be put in lateral decubitus position with the operative side up. Under all aseptic precautions, with a linear probe at 10-12 MHz, the transverse process of L2 vertebrae will be identified, and the paravertebral space will be entered using an 18 G, 10cm Tuohy’s needle. Once the needle is in the paravertebral space, the site is confirmed using hydrolocation technique by injecting 1-2ml normal saline and drugs (25ml of 0.25% ropivacaine) will be injected in the paravertebral space. Following this, a 18G catheter is threaded through the Tuohy’s needle.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
We include all patients between the Ages of 18-60 years undergoing proximal femur surgeries under spinal anesthesia who are having the physical status of ASA grade I and II. |
|
| ExclusionCriteria |
| Details |
Contraindications to regional anaesthesia/Known allergy to local anaesthetics
Bleeding diathesis/Use of any anti-coagulants
Severe kidney or liver disease
Dementia that prevents proper comprehension
Pregnant/Lactating females |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Ultrasound guided continuous Erector spinae plane block versus continuous Paravertebral block for post operative analgesia using the mean maximum Visual Analog Scale score in patients undergoing in proximal fracture femur surgeries |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare VAS score in both blocks in the first 24 hrs., the Time of rescue analgesia and total Requirement of rescue analgesic in 24 hours |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| Date of Study Completion (India) |
10/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The proposed study will be conducted in the Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College, New Delhi, after obtaining written informed consent from all the patients. All patients will undergo a pre-anaesthetic check up with all the relevant investigations. Following the application of the blocks, the patients will be taken up for surgery after giving a subarachnoid block using hyperbaric 0.5% bupivacaine (2.5 ml) + fentanyl (15 microgram). Monitoring of the level of block will be done during surgery and when the level of sensory block recedes to T10, 25ml of 0.5% Ropivacaine will be given through the catheter and a continuous infusion of 0.25% Ropivacaine at the rate of 5ml per hour will be started and continued post operatively for 24hours. |