NCT07445009

Brief Summary

Hip replacement surgery (partial or total hip arthroplasty) is commonly performed in elderly patients and is associated with significant postoperative pain. Effective pain management is critical to support early mobilization, reduce complications, shorten hospital stay, and prevent postoperative delirium.This observational study evaluates the effect of two ultrasound-guided regional analgesia approaches on postoperative pain and recovery quality in patients aged 65 years and older undergoing hip arthroplasty under general anesthesia: Group 1: Pericapsular Nerve Group (PENG) block + Lateral Femoral Cutaneous Nerve (LFCN) block Group 2: PENG block + Lumbar Erector Spinae Plane (ESP) block Both techniques are applied as part of routine clinical practice at our institution. The primary outcome is quality of recovery assessed by the QoR-15 questionnaire at 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, pain scores (NRS), incidence of postoperative delirium (NU-DESC), nausea and vomiting, and time to mobilization. Patients are also followed up by telephone at postoperative day 7 and day 30 for mortality and morbidity assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

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

Study Start

First participant enrolled

July 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

February 25, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

PENG blockErector Spinae Plane BlockLateral Femoral Cutaneous Nerve BlockRegional AnalgesiaQoR-15Quality of RecoveryMultimodal AnalgesiaHip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery (QoR-15 Score)

    Quality of postoperative recovery assessed using the 15-item Quality of Recovery scale (QoR-15). Scores range from 0 to 150, with higher scores indicating better recovery quality. Scores are categorized as excellent (\>135), good (122-135), moderate (90-121), or poor (\<90). Baseline (preoperative) and postoperative 24-hour scores are compared between groups.

    24 hours after surgery

Secondary Outcomes (7)

  • Postoperative Pain Score at Rest

    At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively

  • Postoperative Pain Score on Movement

    At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively

  • Total Tramadol Consumption

    24 hours after surgery

  • Time to First Rescue Analgesic

    24 hours after surgery

  • Incidence of Postoperative Delirium

    At 2, 4, 6, 12, 24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

PENG + LFCN Block

Patients who received ultrasound-guided Pericapsular Nerve Group (PENG) block (20 ml 0.25% bupivacaine) combined with Lateral Femoral Cutaneous Nerve (LFCN) block (5 ml 0.25% bupivacaine) at the end of surgery for postoperative analgesia.

Procedure: PENG + LFCN Block

PENG + ESP Block

Patients who received ultrasound-guided Pericapsular Nerve Group (PENG) block (20 ml 0.25% bupivacaine) combined with Lumbar Erector Spinae Plane (ESP) block (20 ml 0.25% bupivacaine) at the end of surgery for postoperative analgesia.

Procedure: PENG + Lumbar ESP Block

Interventions

Ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 ml 0.25% bupivacaine combined with Lateral Femoral Cutaneous Nerve (LFCN) block with 5 ml 0.25% bupivacaine, applied at the end of surgery.

PENG + LFCN Block

Ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 ml 0.25% bupivacaine combined with Lumbar Erector Spinae Plane (ESP) block with 20 ml 0.25% bupivacaine, applied at the end of surgery.

PENG + ESP Block

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (≥65 years) undergoing elective partial or total hip arthroplasty under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.

You may qualify if:

  • Age 65 years or older
  • ASA physical status I-III
  • Scheduled for elective partial or total hip arthroplasty under general anesthesia
  • Mini-Mental State Examination (MMSE) score ≥24
  • Written informed consent obtained

You may not qualify if:

  • MMSE score below 24
  • Refusal to participate
  • Known allergy to local anesthetics or study medications
  • Coagulation disorders or anticoagulant use contraindicating regional block
  • Infection at the block site
  • Pre-existing chronic pain conditions requiring opioid therapy
  • ASA physical status IV or above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeHip FracturesEmergence Delirium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesDeliriumConfusionNeurobehavioral ManifestationsNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • eda eseroglu gulsen, MD

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

July 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to local ethical and institutional data privacy regulations. Patient confidentiality is protected in accordance with Turkish Personal Data Protection Law (KVKK). Aggregated and de-identified data supporting the findings of this study may be made available upon reasonable request to the corresponding author.

Locations