NCT07770932

Brief Summary

This randomized, prospective study aims to compare the clinical efficacy of ultrasound-guided Deep Subgluteal Block (DSGB) versus Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve (LFCN) block for postoperative analgesia management in patients undergoing hip arthroplasty. A total of 60 patients scheduled for hip arthroplasty under general anesthesia will be randomly allocated into two equal groups of 30: Group DSG and Group PENG+LFCN. Total local anesthetic volume (30 mL) and active drug dose (75 mg bupivacaine) will be standardized across both groups to ensure rigorous blinding and high methodological quality. The primary outcome of the study is to compare total postoperative opioid (fentanyl) consumption within the first 24 hours. Secondary outcomes include postoperative pain scores evaluated via the Numerical Rating Scale (NRS) at rest and during movement, the presence and degree of quadriceps motor block, and opioid-related adverse effects (e.g., nausea, vomiting, pruritus).

Trial Health

77
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 postoperative-pain

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress16%
Aug 2026Jan 2027

Study Start

First participant enrolled

August 1, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 13, 2026

Last Update Submit

August 13, 2026

Conditions

Keywords

Deep Subgluteal Block PENG Block Lateral Femoral Cutaneous Nerve Block Hip Arthroplasty Nerve Block Opioid Consumption

Outcome Measures

Primary Outcomes (1)

  • Cumulative Postoperative Opioid Consumption

    Total intravenous fentanyl consumption (in micrograms) delivered via patient-controlled analgesia (PCA) within the first 24 hours postoperatively.

    First 24 hours postoperatively

Secondary Outcomes (3)

  • Postoperative Pain Scores

    Postoperative hours 0 (PACU), 2, 4, 8, 16, and 24

  • Quadriceps Motor Strength

    Postoperative hours 2, 4, 8, 16, and 24

  • Opioid-Related Adverse Effects

    First 24 hours postoperatively

Study Arms (2)

Group DSG

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided Deep Subgluteal Block using a total of 30 mL of 0.25% bupivacaine (15 mL administered beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle).

Drug: 0.25% Bupivacaine for Deep Subgluteal Block

Group PENG+LCFN

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block. The PENG block will be performed with 20 mL of 0.25% bupivacaine. The LFCN block will be performed using a 10 mL volume consisting of 5 mL of 0.25% bupivacaine diluted with 5 mL of normal saline (0.9% NaCl), resulting in a final local anesthetic concentration of 0.125% bupivacaine at the LFCN site.

Drug: 0.25% and 0.125% Bupivacaine for PENG+LFCN Block

Interventions

Ultrasound-guided regional anesthesia. Patients receive 30 mL of 0.25% bupivacaine, divided as 15 mL beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle.

Group DSG

Ultrasound-guided combination regional anesthesia. Patients receive a PENG block with 20 mL of 0.25% bupivacaine, combined with an LFCN block using 10 mL of 0.125% bupivacaine (5 mL of 0.25% bupivacaine diluted with 5 mL of 0.9% normal saline).

Group PENG+LCFN

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective total or partial hip arthroplasty under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Aged between 18 and 80 years
  • Able to understand the study procedures, give voluntary written informed consent, and operate a patient-controlled analgesia (PCA) device

You may not qualify if:

  • Patient refusal or inability to provide informed consent
  • Pre-existing peripheral neuropathy, cognitive impairment, or psychiatric disorders
  • History of significant severe renal or hepatic failure
  • Allergy or hypersensitivity to amide-type local anesthetics or opioids
  • Infection, severe anatomic distortion, or previous surgery at the proposed block injection sites
  • History of substance abuse or chronic opioid use (defined as daily opioid use for \> 3 months prior to surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol Mega University Hospital

Istanbul, Bagcilar, 34214, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Yunus O Atalay, MD, Prof., DESAIC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the investigator assessing postoperative outcomes are blinded to the group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are randomly assigned to one of the two parallel groups to receive either ultrasound-guided Deep Subgluteal Block or a combination of PENG and LFCN blocks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 18, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations