| CTRI Number |
CTRI/2021/04/032715 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/11/2022 |
| 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
|
Analgesic Efficacy of USG Guided Pericapsular Nerve Group Block Versus Intravenous Nalbuphine Hydrochloride In Patients of bony hip injuries: A Randomised Control Trial |
|
Scientific Title of Study
|
Analgesic Efficacy of USG Guided Pericapsular Nerve Group Block Versus Intravenous Nalbuphine Hydrochloride In Patients of Intracapsular And Pericapsular Bony Hip Injuries: A Randomised Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeeta Sahoo |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no-5, Hospital block, AIIMS Bhubaneswar, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
2472312 |
| Fax |
|
| Email |
drsangeeta.asth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangeeta Sahoo |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
room no-5, Hospital block, AIIMS Bhubaneswar, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
2472312 |
| Fax |
|
| Email |
drsangeeta.asth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishit Kumar Sahoo |
| Designation |
Junior Resident(Academic) |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No-514
PG Hostel-2
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08249187784 |
| Fax |
|
| Email |
kanha.nishit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aiims Bhubaneswar |
| Address |
Department of Trauma Emergency
AIIMS Bhubaneswar-751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Upendra Hansdah |
Room no-6
Hospital Block
AIIMS Bhubaneswar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SANGEETA SAHOO |
AIIMS Bhubaneswar |
Department of Trauma and Emergency
Khordha
ORISSA |
9556547655
drsangeeta.asth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS BHUBANESWAR |
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 |
| Comparator Agent |
Intravenous Nalbuphine Hydrochloride |
Patients undergoing Intravenous Nalbuphine Hydrochloride at 0.15mg/kg body weight |
| Intervention |
pericapsular nerve group block (PENG) |
Patients undergoing PENG block with injection bupivacaine 0.25% 25 ml. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting with traumatic injuries to the hip and radiologically confirmed to be a
1. fracture of surgical neck of the femur
2. intertrochanteric fracture of femur
3. sub capital fracture of the femur
4. fracture of acetabulum
5. fracture of the pubic ramus
6. patients with NRS pain score≥5
|
|
| ExclusionCriteria |
| Details |
1. Infection over the skin at the site of block
2. The shaft of femur fracture
3. Allergic to local anesthetic
4. Coagulopathy
5. Pregnancy
6. Altered mental status
7. Hip Dislocation
8. patient not giving consent
9. patients who received analgesic before the
block
10. Associated with other bony injuries(except the inclusion criteria).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical rating scale (NRS Scale) |
Numerical rating scale (NRS Scale)baseline,30 mins,1 hour,2 hour,4 hour,6 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the need for rescue analgesia in both arms. |
6 hours,12 hours |
| To study the adverse effect in both the arms. |
30 mins,2 hours,4 hours, 6hours, 12 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
19/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip fractures are a harrowing and dangerous orthopaedic emergency that commonly presents to the emergency department. These painful hip fractures are often managed with opioid analgesics like IV morphine or nalbuphine. But most of them are undermedicated in an overcrowded ED setup with limited resources to monitor as there are a lot of undesirable adverse effects like respiratory depression, bradycardia, hypotension and delirium, which gets aggravated especially if used in older patients. An equally effective alternative to IV opioids can be PENG block which is a peripheral nerve block. The PENG block was derived from the femoral nerve’s articular branches, obturator nerve, and accessory obturator nerve that provide sensory innervation to the anterior capsule of the hip joint. It was developed as a safe and potentially more effective alternative to femoral nerve block (FNB) and fascia iliaca block (FIB) for hip injuries. As the injection targets the terminal branches of sensory nerves, it has only a motor-sparing effect facilitating early mobilization. There have only been two case series about PENG block available in the literature, but no RCT has yet been done. This RCT can set a milestone in managing inadequate analgesia in hip fractures in ED set up and better patient compliance. |