Comparison of PENG Block and FICB in Hip Fracture Patients

Comparison of Analgesic Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Dynamic Pain in Patients Undergoing Hip Fracture Surgery: a Randomized Controlled Trial

Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since PENG block could block the accessory obturator nerve, PENG block might have greater analgesic effects compared to FICB theoretically. However, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare the analgesic effect of PENG block and FICB.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Regional Anesthesia
• Intervention / Treatment: Procedure: Pericapsular nerve group (PENG) block; Procedure: Fascia iliaca compartment block (FICB)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA PS 1-4
• age: ≥19
• baseline pain score (associated with hip fracture): ≥4

Exclusion Criteria:

• patients who do not agree to participate in this study
• patients with uncontrolled hypertension, hyperthyroidism, severe dementia
• allergic to ropivacaine
• contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region
• patients who are considered ineligible with any other reason by investigators

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG group; pericapsular nerve group (PENG) block before surgery	Procedure: Pericapsular nerve group (PENG) block; ultrasound-guided PENG block with 0.3% ropivacaine 20cc
Active Comparator: FICB group; suprainguinal fascia iliaca compartment block (FICB) before surgery	Procedure: Fascia iliaca compartment block (FICB); ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of each block (Pain score)	We will assess the dynamic pain (pain during a movement) using NRS before and 20-30min after applying the assigned block. Then, we will calculate the change of NRS at the two time-points. NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)	before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of blood pressure (systolic, diastolic, mean blood pressure)	We will evaluate the blood pressure before and 20-30min after applying the assigned block. Then, we will calculate the change of blood pressure at the two time-points.	before surgery
postoperative pain score	resting and dynamic pain using NRS at postoperative 6, 24, 48hours NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)	postoperative 6, 24, 48hours
postoperative opioid consumption	morphine-equivalent dose	postoperative 24, 48hours
postoperative motor function	motor function of quadriceps femoris grade5: normal power grade4: movement possible against some resistance grade3: movement against gravity but not resistance grade2: movement possible if gravity eliminated grade1: flicker of contraction possible grade0: complete paralysis	postoperative 6, 24, 48hours
change of heart rate	We will evaluate the heart rate before and 20-30 min after applying the assigned block. Then, we will calculate the change of heart rate at the two time-points.	before surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Won Uk Koh, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): February 11, 2022

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: hip fracture; regional anesthesia; fascia iliaca compartment block; pericapsular nerve group block; dynamic pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2020-1822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No