Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively. (PENGBlock)
Primary Purpose
Hip Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip fractures, elderly, pain
Eligibility Criteria
Inclusion Criteria:
- Age 60 years old and above
- Provided consent for the study
- Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
- Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours
Exclusion Criteria:
- Patients with cognitive impairment or inability to give consent, or refusal to give consent
- Multiple fracture cases
- Peri-prosthetic fractures and revisions
- Subclinical vertebral fractures
- Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
- Multiple trauma
- Pathological fractures secondary to metastases
Patients with contraindications to block performance
- Coagulopathy as demonstrated by PT/PTT/INR
- On antiplatelets or anticoagulation
- Infection/ compromised skin integrity at site of block performance
- Allergy to local anaesthetics and opioids
Sites / Locations
- Pain Management Center Sinagpore General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Intervention group
Arm Description
Only standard care
The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.
Outcomes
Primary Outcome Measures
Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group. Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.
Secondary Outcome Measures
Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)
It is measured at Baseline, Immediately after performance of block, 30 minutes after the lock in recovery At 60 minutes, 180 minutes and 24 hours post block in the ward
Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block
Taking the recorded time taken for the pain relieve to estimate onset time using models
Total opioid use over 24 hours as a surrogate measure
Using the data recorded for :
Oral morphine use Intravenous morphine use for patients on PCA Doses of opioid use will be converted to morphine milligram equivalent daily dose (MEDD) for standardized comparison.
Full Information
NCT ID
NCT04996979
First Posted
May 10, 2021
Last Updated
August 2, 2021
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04996979
Brief Title
Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively.
Acronym
PENGBlock
Official Title
Evaluation of the PENG Block vs Placebo for Preoperative Pain Control in Hip Fractures in the Elderly - a Double-blinded Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia.
The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .
Detailed Description
Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.
Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip fractures, elderly, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Patient, nurses and CRC will be blinded. Rest of study team is not blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Only standard care
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Intervention Description
Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Standard care
Intervention Description
Standard care
Primary Outcome Measure Information:
Title
Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
Description
The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group. Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.
Time Frame
30 minutes after receiving intervention
Secondary Outcome Measure Information:
Title
Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)
Description
It is measured at Baseline, Immediately after performance of block, 30 minutes after the lock in recovery At 60 minutes, 180 minutes and 24 hours post block in the ward
Time Frame
Up to 24 hours from performance of block
Title
Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block
Description
Taking the recorded time taken for the pain relieve to estimate onset time using models
Time Frame
Up to 24 hours from performance of block
Title
Total opioid use over 24 hours as a surrogate measure
Description
Using the data recorded for :
Oral morphine use Intravenous morphine use for patients on PCA Doses of opioid use will be converted to morphine milligram equivalent daily dose (MEDD) for standardized comparison.
Time Frame
Up to 24 hours from performance of block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 60 years old and above
Provided consent for the study
Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours
Exclusion Criteria:
Patients with cognitive impairment or inability to give consent, or refusal to give consent
Multiple fracture cases
Peri-prosthetic fractures and revisions
Subclinical vertebral fractures
Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
Multiple trauma
Pathological fractures secondary to metastases
Patients with contraindications to block performance
Coagulopathy as demonstrated by PT/PTT/INR
On antiplatelets or anticoagulation
Infection/ compromised skin integrity at site of block performance
Allergy to local anaesthetics and opioids
Facility Information:
Facility Name
Pain Management Center Sinagpore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Xin Hui Chan
Phone
63266162
Email
diana.chan.x.h@singhealth.com.sg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27075376
Citation
Tay E. Hip fractures in the elderly: operative versus nonoperative management. Singapore Med J. 2016 Apr;57(4):178-81. doi: 10.11622/smedj.2016071.
Results Reference
result
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
result
Links:
URL
https://doi.org/10.1093/bjaceaccp/mkt006
Description
Anaesthetic management of patients with hip fractures: an update
Learn more about this trial
Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively.
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