PENG Block for Traumatic Hip Fracture in the Emergency Department

NCT04997785 | Completed DMC

• 1 other identifier: A10904001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multicenter single-blinded randomized comparative trial. Adult patients older than 20 years of age presenting with acute hip fracture in emergency department between January 1st, 2021 and December 31st, 2021 will be enrolled. (NOTE: The study was paused temporarily due to local SARS-2 COVID-19 virus pandemic restrictions. Finally, we conducted the study from August 30th, 2021 to May 08th, 2022.) Included patients will receive analgesia with either pericapsular nerve group (PENG) block or intravenous morphine. The primary outcome measure was pain scores (Numeric Rating Scale (NRS) 0 to 10) at rest and with movement. Secondary outcomes were rescue opioids use, complications, length of hospital stay, and patient-reported outcomes.

Conditions

Hip Fractures; Acute Pain; Emergency Department

Keywords

Pericapsular Nerve Group Block (PENG Block)

Outcome Measures

Primary Outcomes (1)

• Pain intensity difference (PID)

  Pain intensity was investigated at rest and with movement using the 11-point numeric rating-scale (NRS) from 0 (no pain) to 10 (worst pain), and pain-intensity difference(PID) represents the difference in NRS scores between any observation time and the baseline.

  24 hours

Secondary Outcomes (5)

• postdose quadriceps strength

  24 hours

• Rescue opioid consumption

  24 hours

• Incidence of nerve block complications

  24 hours

• Incidence of opioid side effects

  24 hours

• Patient-reported outcome

  24 hours

Study Arms (2)

Ultrasound-guided Pericapsular Nerve Group (PENG) Block

EXPERIMENTAL

PENG blocks is performed by Emergency Medicine board-certified emergency physicians (EPs) with standard training program. PENG block is performed using a spinal needle (NIPRO® 21G × 70 mm) at the level of of anterior superior iliac spine, parallel to the inguinal crease, with real-time ultrasound guidance, according to the steps published by Girón-Arango et al in 2018. The investigators use 20 ml of 1% lidocaine for nerve block because this drug has a short onset time, which is adequate to relieve pain before surgical intervention.

Procedure: Ultrasound-guided Pericapsular Nerve Group (PENG) Block

Intravenous Morphine

ACTIVE COMPARATOR

Dosage of intravenous morphine was determined according to 0.1 mg per kg; EPs were instructed to aim to reduce the pain by 50% or per patient request.

Procedure: Ultrasound-guided Pericapsular Nerve Group (PENG) Block

Interventions

Ultrasound-guided Pericapsular Nerve Group (PENG) Block PROCEDURE

PENG blocks is performed by Emergency Medicine board-certified emergency physicians (EPs) with standard training program. PENG block is performed using a spinal needle (NIPRO® 21G × 70 mm) at the level of of anterior superior iliac spine, parallel to the inguinal crease, with real-time ultrasound guidance, according to the steps published by Girón-Arango et al in 2018. The investigators use 20 ml of 1% lidocaine for nerve block because this drug has a short onset time, which is adequate to relieve pain before surgical intervention.

Intravenous Morphine; Ultrasound-guided Pericapsular Nerve Group (PENG) Block

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>20 years presenting to the ED with a diagnosis of traumatic hip fracture during the study timeframe.

You may not qualify if:

• are aged \<20 years
• coagulopathy
• injection site infection
• allergy to opioids or local anesthetics
• initial pulse oximetry measures of oxygen saturation \<92%
• initial systolic blood pressure \< 90 mmHg
• chronic opioid use
• non-communicative
• major trauma
• fractures happened \> 24 hours
• request conservative(non-operative) treatments.
• The investigators also exclude patients if the NB providers are unavailable.

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead
• Far Eastern Memorial Hospital: collaborator

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, 622, Taiwan

Location

MeSH Terms

Conditions

Hip Fractures; Acute Pain; Emergencies

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency department physician, Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 10, 2021
• Study Start: August 30, 2021
• Primary Completion: May 8, 2022
• Study Completion: May 8, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

TW (1)