NCT07288983

Brief Summary

This randomized, double-blinded, controlled clinical trial compares three motor-sparing regional anesthesia techniques used for postoperative analgesia in patients undergoing hip arthroplasty: the Pericapsular Nerve Group (PENG) block, the suprainguinal Fascia Iliaca Compartment Block (S-FICB), and the Lumbar Erector Spinae Plane Block (L-ESPB). Although all three techniques are widely used in modern hip surgery, their relative analgesic efficacy, opioid-sparing potential, and impact on early functional recovery have not been directly compared in a single study. The primary objective is to determine which block provides the most effective postoperative analgesia while preserving motor function and facilitating early mobilization. Secondary objectives include comparisons of opioid consumption, pain scores at rest and during movement, time to first rescue analgesia, block-related adverse events, quadriceps strength, incidence of postoperative nausea and vomiting, and early functional outcomes. This study aims to identify the optimal motor-sparing regional anesthesia strategy for older adults undergoing hip arthroplasty.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Feb 2026

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 Progress25%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

March 4, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 4, 2025

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption in the First 48 Hours After Surgery

    Total cumulative opioid consumption recorded in the first 48 postoperative hours, converted to morphine milligram equivalents (MME). Includes all opioid medications administered as part of postoperative analgesia, both scheduled and rescue doses. Data will be extracted from electronic medication records and converted using standard MME conversion factors.

    0-48 hours postoperatively

Secondary Outcomes (19)

  • Time to First Rescue Opioid Administration

    0-48 hours postoperatively

  • Numerical Rating Scale (NRS) Pain Scores at Rest

    4 hours postoperatively

  • Numerical Rating Scale (NRS) Pain Scores at Rest

    8 hours postoperatively

  • Numerical Rating Scale (NRS) Pain Scores at Rest

    12 hours postoperatively

  • Numerical Rating Scale (NRS) Pain Scores at Rest

    24 hours postoperatively

  • +14 more secondary outcomes

Study Arms (3)

PENG block

ACTIVE COMPARATOR

Participants in this arm will receive a Pericapsular Nerve Group (PENG) block performed under ultrasound guidance. The block will be administered with 20 mL of 0.2% ropivacaine injected lateral to the iliopsoas tendon at the level of the anterior inferior iliac spine and iliopubic eminence. No additional peripheral nerve blocks will be performed. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia.

Procedure: Pericapsular Nerve Group (PENG) Block

Suprainguinal FICB

ACTIVE COMPARATOR

Participants will receive a suprainguinal Fascia Iliaca Compartment Block (S-FICB) performed under ultrasound guidance. A total of 40 mL of 0.2% ropivacaine will be injected in the suprainguinal fascia iliaca plane to achieve spread toward the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia.

Procedure: Suprainguinal Fascia Iliaca Compartment Block (S-FICB)

Lumbar ESPB

ACTIVE COMPARATOR

Participants will receive a lumbar Erector Spinae Plane Block (L-ESPB) performed under ultrasound guidance at the L4 transverse process level. A total of 20 mL of 0.2% ropivacaine will be injected deep to the erector spinae muscle and superficial to the transverse process. No sacral ESPB will be added. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia.

Procedure: Lumbar Erector Spinae Plane Block (L-ESPB)

Interventions

The Pericapsular Nerve Group (PENG) block will be performed under ultrasound guidance using a curvilinear or linear transducer. A 22-gauge echogenic needle will be advanced in-plane toward the fascial plane between the iliopsoas tendon and the pelvic brim at the level of the anterior inferior iliac spine. A total of 20 mL of 0.2% ropivacaine will be injected incrementally with repeated aspiration to avoid intravascular injection. No additional peripheral nerve blocks will be performed. All patients will receive standardized spinal anesthesia and multimodal postoperative analgesia.

PENG block

The suprainguinal fascia iliaca compartment block will be performed under ultrasound guidance using a high-frequency linear probe placed in the sagittal oblique plane above the inguinal ligament. After identifying the fascia iliaca above the iliacus muscle, a 22-gauge echogenic needle will be advanced in-plane into the suprainguinal fascia iliaca space. A total of 30 mL of 0.2% ropivacaine will be injected to achieve cranial spread toward the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. All patients will receive standardized spinal anesthesia and multimodal postoperative analgesia.

Suprainguinal FICB

The lumbar erector spinae plane block will be performed under ultrasound guidance at the L4 transverse process level. A curvilinear or linear ultrasound probe will be used to identify the erector spinae muscle and underlying transverse process. A 22-gauge echogenic needle will be inserted in-plane and advanced to the fascial plane deep to the erector spinae muscle and superficial to the transverse process. A total of 20 mL of 0.2% ropivacaine will be injected incrementally. No sacral ESPB will be added. All patients will receive standardized spinal anesthesia and multimodal postoperative analgesia.

Lumbar ESPB

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adults aged 65 years or older scheduled to undergo elective hip arthroplasty under spinal anesthesia.
  • Ability to provide written informed consent.
  • Ability to understand and reliably use numerical pain assessment tools (NRS 0-10).
  • ASA physical status II-III.
  • Expected postoperative hospitalization of at least 48 hours to ensure complete data collection.

You may not qualify if:

  • Inability to provide informed consent due to cognitive impairment, language barrier, or severe hearing/speech limitations.
  • Coagulopathy or therapeutic anticoagulation not meeting safety criteria for regional anesthesia.
  • Local infection at the planned block site.
  • Allergy, hypersensitivity, or contraindication to ropivacaine, local anesthetics, or study medications.
  • Pre-existing lower-limb neurological deficits (motor or sensory) affecting outcome assessments.
  • Severe spinal deformity or anatomical limitations preventing safe performance of regional blocks.
  • Chronic opioid use (defined as \>30 mg oral morphine equivalents daily for more than 2 weeks).
  • Severe renal failure (eGFR \<30 mL/min/1.73m²) or severe hepatic impairment.
  • Uncontrolled diabetes mellitus (fasting glucose \>300 mg/dL or HbA1c \>10%).
  • History of local anesthetic systemic toxicity (LAST).
  • Participation in another interventional clinical trial within the past 30 days.
  • Any condition deemed by investigators to interfere with protocol adherence, safety monitoring, or outcome reliability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Malgorzata Reysner, MD PhD

    Poznań University of Medicla Sciences

    STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

February 6, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

March 4, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be made available to other researchers upon reasonable request. Shared data will include demographic variables, intraoperative information, block-related details, pain scores, opioid consumption, motor assessments, and adverse events. No direct identifiers or protected health information will be included.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD and supporting documents will become available 12 months after publication of the primary results and will remain accessible for 5 years.
Access Criteria
Researchers must submit a methodologically sound proposal describing the intended use of the data. Requests will be reviewed by the study investigators. Data will be shared through secure, password-protected transfer methods. A data-sharing agreement will be required before access is granted.

Locations