CTRI Number |
CTRI/2021/08/036083 [Registered on: 31/08/2021] Trial Registered Prospectively |
Last Modified On: |
22/08/2021 |
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
|
Which block has better efficacy USG guided Pericapular Nerve Group Block versus Lumbar Plexus Block for postoperative analgesia in patients undergoing hip surgery |
Scientific Title of Study
|
A randomised controlled trial to assess the efficacy of Pericapsuler Nerve Group Block verses Lumbar Plexus 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 |
SUNIL KUMAR SINHA |
Designation |
Professor |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of anaesthesiology, Lady Hardinge Medical College
Department of anaesthesiology, Lady Hardinge Medical College
Central DELHI 110001 India |
Phone |
9868493597 |
Fax |
|
Email |
sunilsinha248@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SUNIL KUMAR SINHA |
Designation |
Professor |
Affiliation |
Lady Hardinge Medical College |
Address |
Department of anaesthesiology, Lady Hardinge Medical College
Central DELHI 110001 India |
Phone |
9868493597 |
Fax |
|
Email |
sunilsinha248@gmail.com |
|
Details of Contact Person Public Query
|
Name |
ARSHAN ALI |
Designation |
Post Graduate Student |
Affiliation |
Lady Hardinge Medical College, |
Address |
Department of anaesthesiology, Lady Hardinge Medical College
Department of anaesthesiology, Lady Hardinge Medical College
Central DELHI 110002 India |
Phone |
8700898608 |
Fax |
|
Email |
arshan47ali@gmail.com |
|
Source of Monetary or Material Support
|
Department of anaesthesiology, Lady Hardinge Medical College, Central Delhi |
|
Primary Sponsor
|
Name |
Lady Hardinge Medical College |
Address |
Shaheed Bhagat Singh Marg, Central 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 ARSHAN ALI |
Lady Hardinge Medical College |
Department of anaesthesiology,
Lady Hardinge Medical College,
Shaheed Bhagat Singh; Marg,Central Delhi Central DELHI |
8700898608
arshan47ali@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee for human research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Lumbar Plexus Block |
Nerve stimulator used along with USG guidance by using needle 22G needle |
Comparator Agent |
Pericapsular Nerve Group Block |
By using low frequency USG guided needle |
|
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 |
1.Any known drug allergies.
2.Contraindication to nerve block like coagulopathy, bleeding diathesis and local infection
3.Patient requires general anaesthesia during surgery
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mean opioid consumption (in mg/kg) at the end of 24 hours postoperatively in both PENG block and lumbar plexus block group |
Mean opioid consumption (in mg/kg) at the end of 24 hours postoperatively in both PENG block and lumbar plexus block group |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Mean NRS on rest at 0, 4, 8, 12&24 hr postoperatively in both the group
2.Mean NRS on limb movement at 0, 4, 8, 12&24 hr postoperatively in both the group
3.Proportion of patient developing Nausea, vomiting, numbness, sedation and motor weakness
|
24hour |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
07/09/2021 |
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="2" Days="2" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Results will be published in a scientific journal |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Hip fracture is a common orthopedic emergency, & associated with significant morbidity and mortality. Surgical reduction and fixation is the definitive treatment in most patients to improve mobility and quality of life. Adequate pain relief is essential in the postoperative period to enable ambulation and initiation of physiotherapy. Various methods have been used to provide post op analgesia. Intravenous patient-controlled analgesia (IV PCA) or epidural analgesia are the most common methods. IV PCA is associated with poor pain control and opioid associated complications. Epidural analgesia may lead to hemodynamic instability and bilateral motor block. Recently, peripheral nerve blockade has emerged alternative analgesic approach.4 Femoral nerve block and fascia illiaca block are useful however they are associated with inadequate pain control for hip surgery because of low propensity to block obturator nerve. Lumbar plexus block or psoas compartment blocks has been considered Gold standard, as it reliably block all its branches including obturator nerve and provide potent analgesia with reduce opioid consumption for hip surgery. It is a deep block and technically challenging even with the use of ultrasound. Recently ultrasound guided Pericapsular Nerve Group (PENG) block has been described which block articular branches of hip supplied by femoral, obturator, and accessory obturator nerve. Technique for PENG block is easy as it is quite superficial as well as initial data on its application and hip surgery is in encouraging. |