NCT06267716

Brief Summary

This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery. The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement. Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group. Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 13, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

February 13, 2024

Last Update Submit

January 11, 2026

Conditions

Keywords

iliopsoas plane blockpericapsular nerve group blockHip Fracturespostoperative painmotor weakness

Outcome Measures

Primary Outcomes (1)

  • pain scores

    numeric rating scales as (NRS) which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain. NRS scores were evaluated at several time points. Prior to data analysis, the primary outcome was revised due to the unexpectedly low incidence of clinically detectable postoperative motor dysfunction observed during trial conduct, which limited its discriminative value. Pain-related outcomes were therefore designated as primary to better reflect clinically meaningful differences between interventions.

    postoperative 24 hour

Secondary Outcomes (3)

  • postoperative motor block

    postoperative 24 hour

  • total analgesia, intraoperative

    intraoperatively

  • total rescue analgesia

    postoperative 24 hour

Study Arms (2)

PENG block

ACTIVE COMPARATOR

Immediately after the insurance of general anaesthesia and LFCN block application, PENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic (20 ml 0,375% bupivacaine) was injected between the periosteum and psoas tendon following negative aspiration.

Procedure: PENG block

IPP block

EXPERIMENTAL

After ensuring aseptic conditions, the low-frequency curvilinear ultrasound probe was transversely placed caudad to the anterior superior iliac spine, then rotated anticlockwise and slid along the inguinal ligament to detect the head of the femur, as described by Nielsen et al. The primary investigator (B.C.) directed the needle tip into the iliopsoas plane between the iliopsoas muscle and iliofemoral ligament through an in-plane approach, and 10 ml of 0,375% bupivacaine was injected.

Procedure: IPB

Interventions

PENG blockPROCEDURE

preoperative ultrasound-guided pericapsular nerve group block

PENG block
IPBPROCEDURE

preoperative ultrasound-guided iliopsoas plane block

IPP block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients were excluded if they had one of the following criteria: refusal to participate, a history of neurological deficits or neuropathy affecting the lower extremity, infection at the site of block application, coagulopathy; allergy to local anaesthetics, epilepsy or treatment with antipsychotics; abuse of alcohol or drugs; previous surgery distorting the anatomy of the inguinal or supra inguinal areas; severe organ dysfunction ( kidney, liver and other); uncooperative patients who fail to respond reliably to verbal pain assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

Location

Related Publications (2)

  • Jessen C, Brix LD, Nielsen TD, Espelund US, Lund B, Bendtsen TF. Efficacy of iliopsoas plane block for patients undergoing hip arthroscopy: a prospective, triple-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2025 Jan 7;50(1):5-10. doi: 10.1136/rapm-2023-104989.

    PMID: 38050149BACKGROUND
  • Yeoh SR, Chou Y, Chan SM, Hou JD, Lin JA. Pericapsular Nerve Group Block and Iliopsoas Plane Block: A Scoping Review of Quadriceps Weakness after Two Proclaimed Motor-Sparing Hip Blocks. Healthcare (Basel). 2022 Aug 18;10(8):1565. doi: 10.3390/healthcare10081565.

    PMID: 36011222BACKGROUND

MeSH Terms

Conditions

Hip FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Berna Caliskan, MD

    Haseki Training and Research Hospital Anesthesiology and Reanimation Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participants under general anaesthesia and the orthopaedic surgeon responsible for the study will be blinded to the study groups and the specific block procedures. This surgeon will serve as the sole evaluator of postoperative outcomes. Intraoperative results will be recorded by the anaesthesia technician, who is present in the operating room and unaware of the block procedures. Moreover, the data analysis will be conducted before the data are unblinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective randomized standardized triple-blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 20, 2024

Study Start

February 23, 2024

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

January 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations