| CTRI Number |
CTRI/2020/09/027663 [Registered on: 08/09/2020] Trial Registered Prospectively |
| Last Modified On: |
13/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is Erector Spinae Plane block a replacement for epidural analgesia for pain relief after Hip replacement surgery? A comparative study. |
|
Scientific Title of Study
|
Comparison of the post-operative analgesic efficacy of Lumbar Erector Spinae Plane Block versus that of Epidural Blockade in hip replacement surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mathew George |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences And Research Centre |
| Address |
Department of Anaesthesiology,
Amrita Institute of Medical Sciences and Research centre,
AIMS P.O., Ponekkara,
Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
9447841795 |
| Fax |
|
| Email |
mathew.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mathew George |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences And Research Centre |
| Address |
Kodiyattil,
Kadungallur Rd.,
Thottakattukara P.O.,
Aluva, Ernakulam
Department of Anaesthesiology,
Amrita Institute of Medical Sciences and Research centre,
AIMS P.O., Ponekkara,
Ernakulam
KERALA
683108
India |
| Phone |
9447841795 |
| Fax |
|
| Email |
mathew.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devi Padmakumar |
| Designation |
Junior Resident-Year 2 |
| Affiliation |
Amrita Institute of Medical Sciences And Research Centre |
| Address |
Department of Anaesthesiology,
Amrita Institute of Medical Sciences and Research centre,
AIMS P.O., Ponekkara,
Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
9496096185 |
| Fax |
|
| Email |
devi.pkumar93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Center,
AIMS P.O., Edapally
Ernakulam,
Kerala 682041
India |
|
|
Primary Sponsor
|
| Name |
Dr Mathew George |
| Address |
"Kodiyattil",
Kadungallur Rd,
Thottakattukara P.O.,
Aluva, 683108 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Amritha Institute Of Medical Sciences and Research Center |
AIMS P.O.,
Edapally, Ernakulam
Kerala 682041
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mathew George |
Amrita Institute of Medical Sciences & Research Centre |
Department of Anaesthesiology,
Amrita Institute of Medical Sciences and Research centre,
AIMS P.O., Ponnekara,
Ernakulam 682041
Ernakulam
KERALA |
9447841795
mathew.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIMS , Kochi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M160||Bilateral primary osteoarthritis of hip, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: M131||Monoarthritis, not elsewhere classified, (4) ICD-10 Condition: M16||Osteoarthritis of hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lumbar Epidural Blockade |
A lumbar epidural block will be placed using an epidural catheter placed at the beginning of the surgery, through which local anaesthetic drug Ropivacaine 0.2% will be administered. |
| Intervention |
Lumbar Erector Spinae Plane Blockade |
Local anaesthetic drug is deposited using ultrasound guidance between the erector spinae muscle and the lumbar transverse process |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients planned for elective hip replacement surgery belonging to American Society of Anesthetists Physical Status 1 to 3 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Known allergy to local anesthetics
3. Infection at site
4. Bleeding diathesis or patients on any anti-coagulants
5. Inability to provide informed consent
6. ASA PS 4 or 5 patients.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequacy of analgesia as assessed by the Numeric Rating Score for post -operative acute pain, and difference in narcotic consumption between the 2 groups |
Hourly for the first 6 hours postoperatively and second hourly after that up to 24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of analgesic technique related adverse effects or complications in the post-operative period. This includes hypotension, urinary retention, paraesthesia, bleeding from block site and motor blockade |
Hourly for the first 6 hours postoperatively and second hourly after that up to 24 hours post-operatively |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/09/2020 |
| Date of Study Completion (India) |
30/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are attempting to compare a new analgesic block- erector spinal plane block, to the current standard analgesia after hip surgery that is epidural analgesia. Epidural analgesia is associated with certain shortcomings in the postoperative period, and thus erector spinal plane block is being evaluated as a suitable alternative. Our study design aims to include patients undergoing hip arthroplasty surgery who will be randomised to receive either technique. Participants will be blinded to the analgesic technique being used. Postoperatively the patients will be evaluated for 24 hours by the attending nursing staff in the recovery area with special emphasis on their pain relief as assessed by Numerical Rating Scale (1-10) and incidence of any complications if any, with respect to the analgesic technique provided. All patients will be given supplemental analgesia with intravenous agents in case their block appears to be ineffective. We will be analysing based on a Number Needed to treat analysis. |