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

Evaluation of the PENG Block vs Placebo for Preoperative Pain Control in Hip Fractures in the Elderly - a Double-blinded Randomised Controlled Trial

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 .

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine 0.5% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • Pain Management Center Sinagpore General Hospital
    • Contact: Diana Xin Hui Chan; Phone Number: 63266162; Email: diana.chan.x.h@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Only standard care	Drug: Placebo; Standard care; Other Names: Standard care
Experimental: Intervention group; The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.	Drug: Ropivacaine 0.5% Injectable Solution; Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Anaesthetic management of patients with hip fractures: an update

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Hip fractures, elderly, pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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