| CTRI Number |
CTRI/2022/11/047702 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| 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
|
A study to compare the effectiveness of Pericapsular nerve group block versus erector spinae plane block for pain control after hip surgery |
|
Scientific Title of Study
|
A randomized controlled trial to compare the efficacy of pericapsular nerve group block versus erector spinae plane block for postoperative analgesia in patients undergoing hip surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha |
| Designation |
Post graduation student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
nehamyid08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Hayaran |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Hayaran |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg |
| 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 |
| Neha |
Lady Hardinge Medical College |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central
DELHI |
9958114077
nehamyid08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research, LHMC and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
Ultrasound guided lumbar erector spinae plane block given in lateral position using 20 ml of 0.25% plain bupivacaine with 8 mg dexamethasone in hip surgery patients 15 minutes before giving spinal anaesthesia.Then postoperative pain will be assessed at 0,4,12 and 24hours. |
| Comparator Agent |
Pericapsular nerve groups block |
Ultrasound guided pericapsular nerve group block given in supine position using 20 ml of 0.25% plain bupivacaine with 8 mg dexamethasone in hip surgery patients 15 minutes before giving spinal anaesthesia.Then postoperative pain will be assessed at 0,4,12 and 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients ASA I and ASA II 18-70 years posted for hip surgery |
|
| ExclusionCriteria |
| Details |
Any known drug allergies Contraindication to nerve block like coagulopathy, bleeding diathesis and local infection Patient requires general anaesthesia during surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean opioid consumption at the end of 24 hours postoperatively |
At end of 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Median grading of ease of spinal positioning after 15 minutes of block.
2.Mean time to first rescue analgesic demand in hours.
3.Median NRS on rest and location of pain at 0,4,12 and 24 hours postoperatively.
4.Median NRS on movement and location of pain at 0,4,12 and 24 hours postoperatively.
5.Proportion of patients developing complications. |
1.After 15 minutes of block
2.NRS at 0,4,12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nehamyid08@gmail.com].
- For how long will this data be available start date provided 01-02-2024 and end date provided 01-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Hip surgery is the definitive management for hip fracture. Postoperative pain increases complications,morbidity and delays recovery. Hence various methods such as epidural analgesia, IV patient controlled analgesia and peripheral nerve blockade procedures are done to decrease postop pain. In this study we are comparing the analgesic efficacy of pericapsular nerve group block versus erector spinae plane block using ultrasound after explaining the entire procedure to the patient and taking consent. Patient will be explained about the NRS scale beforehand. Patient will be taken on OT table ,all the monitors will be attached. NRS will be assessed in supine position and on limb movement.20 ml of 0.25% bupivacaine(plain) with 8mg of dexamethasone will be given in both the blocks. After 15 minutes patient will be made to sit for giving subarachnoid block and ease of spinal positioning will be assessed. In the postoperative period pain is assessed at 0,4,12 and 24 hours.Time at which first rescue analgesic taken will also be noted. Any opioid consumption within 24 hrs will be noted.Proportion of patients developing complications will also be noted.The efficacy of the two groups will be compared on these parameters. |