NCT04677348

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

December 10, 2020

Last Update Submit

March 21, 2022

Conditions

Hip FracturesRegional Anesthesia

Keywords

pericapsular nerve group blockfascia iliaca compartment blockhip fractureregional anesthesiadynamic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • change of blood pressure (systolic, diastolic, mean blood pressure)

    before surgery

  • postoperative pain score

    postoperative 6, 24, 48hours

  • postoperative opioid consumption

    postoperative 24, 48hours

  • postoperative motor function

    postoperative 6, 24, 48hours

  • change of heart rate

    before surgery

Study Arms (2)

PENG group

EXPERIMENTAL

pericapsular nerve group (PENG) block before surgery

Procedure: Pericapsular nerve group (PENG) block

FICB group

ACTIVE COMPARATOR

suprainguinal fascia iliaca compartment block (FICB) before surgery

Procedure: Fascia iliaca compartment block (FICB)

Interventions

Pericapsular nerve group (PENG) blockPROCEDURE

ultrasound-guided PENG block with 0.3% ropivacaine 20cc

PENG group
Fascia iliaca compartment block (FICB)PROCEDURE

ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc

FICB group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Koh WU, Kim H, Kim YJ, Park JI, Yeo HJ, Ro YJ, Kim HJ. Comparison of analgesic effect of pericapsular nerve group block and supra-inguinal fascia iliaca compartment block on dynamic pain in patients with hip fractures: a randomized controlled trial. Reg Anesth Pain Med. 2025 Aug 5;50(8):635-640. doi: 10.1136/rapm-2024-105627.

    PMID: 38866559DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Won Uk Koh, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 21, 2020

Study Start

January 21, 2021

Primary Completion

January 26, 2022

Study Completion

February 11, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)