Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively.

Hip Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04996979
• Other study ID #: 2
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age 60 years old and above

2. Provided consent for the study

3. Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture

4. Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours

Exclusion Criteria:

1. Patients with cognitive impairment or inability to give consent, or refusal to give consent

2. Multiple fracture cases

3. Peri-prosthetic fractures and revisions

4. Subclinical vertebral fractures

5. Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters

6. Multiple trauma

7. Pathological fractures secondary to metastases

8. 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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)
• Placebo
Standard care

Locations

Country	Name	City	State
Singapore	Pain Management Center Sinagpore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Girón-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes after receiving intervention
Secondary	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	Up to 24 hours from performance of block
Secondary	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	Up to 24 hours from performance of block
Secondary	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.	Up to 24 hours from performance of block

External Links

•   Anaesthetic management of patients with hip fractures: an update