| CTRI Number |
CTRI/2021/04/032741 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2022 |
| 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
|
Effectiveness of Erector spinae plane block using Ultrasound machine for providing post-operative pain relief in Hip joint and proximal femur surgeries. |
|
Scientific Title of Study
|
Efficacy of ultrasound guided erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries- A randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hetal Kotecha |
| Designation |
Resident Doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College and SSG Hospital, Vadodara |
| Address |
Department of Anaesthesiology, Government Medical College and SSG Hospital, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
6352816828 |
| Fax |
|
| Email |
hetalkotecha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Lalchandani |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College and SSG Hospital, Vadodara |
| Address |
Department of Anaesthesiology
Government Medical College and SSG Hospital, Anandpura Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9274586809 |
| Fax |
|
| Email |
lalchandanikavita@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Lalchandani |
| Designation |
Associate professor in Department of Anaesthesiology |
| Affiliation |
Government Medical College and SSG Hospital, Vadodara |
| Address |
Department of Anaesthesiology
Government Medical College and SSG Hospital, Anandpura Vadodara
Rajkot
GUJARAT
390001
India |
| Phone |
9274586809 |
| Fax |
|
| Email |
lalchandanikavita@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Vadodara |
|
|
Primary Sponsor
|
| Name |
Hetal Kotecha |
| Address |
Room no 73, Internee girls hostel, near superintendent office, Baroda medical college and SSG Hospital, Anandpura, Vadodara-390001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hetal Kotecha |
Government medical college and SSG Hospital, Vadodara |
Orthopedic operation theatre, 1st floor, new surgical block, SSG Hospital and Government Medical College, Anandpura, Vadodara
Vadodara
GUJARAT |
6352816828
hetalkotecha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research, Government Medical College, Vadodara |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: S721||Pertrochanteric fracture, (4) ICD-10 Condition: M165||Unilateral post-traumatic osteoarthritis of hip, (5) ICD-10 Condition: M167||Other unilateral secondary osteoarthritis of hip, (6) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, (7) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (8) ICD-10 Condition: M163||Unilateral osteoarthritis resulting from hip dysplasia, (9) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
Ultrasound guided lumbar erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries |
| Comparator Agent |
Injection tramadol |
Injection tramadol 1.5 mg/kg intravenous in 100 ml Normal saline as infusion post-operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grading- I,II,III
Patient posted for hip joint and proximal femur surgeries
Patient able to give verbal and informed consent
Patient able to understand VAS regarding assessment of Pain |
|
| ExclusionCriteria |
| Details |
Patient not willing
Allergy to local anesthetics
Contraindication of spinal, regional anaesthesia
Patient with coagulopathy, local infection
Patient with pre-existing neurological deficits
Patient with history of drug or alcohol abuse, psychiatric illness
Patient with pelvic fracture |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of Analgesia and
No of Rescue analgesic requirement within 24 hours |
Pain will be assessed using VAS (Visual Analogue Scale) score every 1 hour for first 6 hours and every 6 hours for next 24 hours
Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg iv at VAS score more than 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vital parameters and
Complications associated with block |
Vital parameters will be monitored before giving the block, immediately after giving the block, at 2, 5, 10, 30, 60 minutes |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
01/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
- Aim of the study is to know efficacy of ultrasound guided erector spinae plane block for post-operative pain relief in hip joint and proximal femur surgeries.
- Patients suitable for study as per inclusion criteria, admitted in SSG Hospital will be selected.
- Demographic details, History, Investigations will be assessed and general examination, systemic examination will be done
- Patients will be randomly divided into two groups after surgery being done under spinal anaesthesia. 3 ml of Hyperbaric bupivacaine 0.5% will be given in spinal anaesthesia.
- Case group will be given ultrasound guided lumbar erector spinae plane block 4-6 cm lateral to spinous process and superficial to transverse process of L4 vertebra in the erector spinae plane. Total 30 cc local anaesthetic drug- 0.25% Bupivacaine will be injected using convex ultrasound transducer probe using out plane approach.
- Control group will be given injection tramadol 1.5 mg/kg intravenously in 100 ml Normal saline as infusion.
- Patients will be monitored for duration of analgesia using VAS score, Rescue analgesics required in 24 hours, Vital parameters and complications associated with block.
- VAS (Visual Analogue Scale) score will be assessed every 1 hourly for first 6 hours and every 6 hourly for next 24 hours.
- Rescue analgesia will be given in the form of Injection Paracetamol 15 mg/kg intravenously at VAS score>4.
|