NCT07449585

Brief Summary

The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. The application of this technique reduces postoperative opioid requirements, thereby limiting the risk of adverse effects associated with systemic opioid administration. Effective pain control and a reduced incidence of side effects may translate into higher patient satisfaction and a decreased length of hospital stay (LOS). The PENG block serves as an effective component of multimodal analgesia and may provide an alternative to intrathecal morphine in patients undergoing primary total hip arthroplasty via a posterolateral approach, where the primary anesthetic technique is spinal anesthesia with hyperbaric bupivacaine. Objectives

  1. 1.To evaluate the efficacy of the PENG block in postoperative pain control and compare its effectiveness with intrathecal morphine administration.
  2. 2.To assess the impact of the PENG block on postoperative opioid consumption in comparison to analgesia achieved via intrathecal morphine.
  3. 3.To analyze the incidence of selected adverse effects associated with systemic opioid administration in patients receiving a PENG block versus those in the intrathecal morphine group.
  4. 4.To evaluate patient satisfaction levels regarding postoperative pain management across the different analgesic modalities.
  5. 5.To analyze the correlation between the type of analgesia employed and the duration of hospitalization.

Trial Health

65
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Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet 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 Progress15%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

February 5, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

February 5, 2026

Last Update Submit

March 1, 2026

Conditions

Perioperative AnalgesiaHip Replacement, TotalPostoperative PainHip Disease

Keywords

Pericapsular Nerve Group BlockIntrathecal MorphineSpinal AnesthesiaTotal Hip ArthroplastyPostoperative PainPostoperative AnalgesiaOpioid ConsumptionPatient-Controlled Analgesia

Outcome Measures

Primary Outcomes (5)

  • Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA)

    Total amount of oxycodone delivered by the intravenous PCA pump, calculated as the sum of all delivered PCA boluses and reported in milligrams. Lower values indicate lower postoperative opioid requirement.

    From end of surgery to 24 hours postoperatively.

  • Number of patient-initiated PCA demand attempts recorded by the PCA pump

    Total number of patient-initiated analgesia requests (button presses) recorded by the intravenous patient-controlled analgesia (PCA) pump. This measure includes all demand attempts, regardless of whether a bolus was delivered. Reported as count.

    From end of surgery to 24 hours postoperatively.

  • Pain intensity at rest measured by the 11-point Numerical Rating Scale (NRS, 0-10)

    Patient-reported pain intensity at rest assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.

    Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  • Dynamic pain assesmnetDynamic pain intensity during passive straight leg raise measured by the 11-point Numerical Rating Scale (NRS, 0-10)

    Patient-reported dynamic pain intensity during passive straight leg raise of the operated limb (knee extended and hip flexed to 45°), assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.

    Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.

  • Patient satisfaction with postoperative analgesia measured by a 5-point Likert satisfaction scale (1-5)

    Patient-reported satisfaction with postoperative analgesia assessed using a 5-point Likert satisfaction scale: 1. = definitely dissatisfied, 2. = dissatisfied, 3. = neither satisfied nor dissatisfied (neutral), 4. = satisfied, 5. = definitely satisfied. Higher scores indicate greater satisfaction.

    At 0, 4, 8, 12, and 24 hours after surgery.

Secondary Outcomes (17)

  • Nausea severity

    Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively

  • Pruritus Severity

    Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively

  • Postoperative length of hospital stay (days)

    From hospital admission to hospital discharge (assessed at hospital discharge).

  • Sedation and agitation level measured by the Richmond Agitation-Sedation Scale (RASS, -5 to +4)

    At 0, 4, 8, 12, and 24 hours after surgery.

  • Motor blockade measured by the Bromage motor blockade scale (Grade 0-3)

    At 0, 4, 8, 12, and 24 hours after surgery.

  • +12 more secondary outcomes

Study Arms (3)

PENG Group

EXPERIMENTAL

Spinal anesthesia without opioid + PENG block

Procedure: PNEG blockProcedure: Spinal anesthesia without opioid

MF Group

ACTIVE COMPARATOR

Spinal anesthesia with opioid and sham PENG Block

Procedure: Spinal anesthesia with opioidProcedure: Sham PENG block

Control

SHAM COMPARATOR

Spinal anesthesia without opioid and sham PENG Block

Procedure: Spinal anesthesia without opioidProcedure: Sham PENG block

Interventions

PNEG blockPROCEDURE

Pericapsular Nerve Group (PENG) block will be performed using 20 mL of 0.5% ropivacaine (Ropimol, Molteni, Italy), supplemented with 4 mg of dexamethasone (Dexaven, Bausch Health, Ireland).

PENG Group
Spinal anesthesia with opioidPROCEDURE

Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine, supplemented with 100 mcg of morphine (Morphini Sulfas WZF 0.1% Spinal, Polpharma, Poland).

MF Group
Spinal anesthesia without opioidPROCEDURE

Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).

ControlPENG Group
Sham PENG blockPROCEDURE

A sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).

ControlMF Group

Eligibility Criteria

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

You may qualify if:

  • Informed, written consent for study participation.
  • Qualification for elective primary total hip arthroplasty via a posterolateral approach.
  • Age above 18 years.
  • ASA Physical Status I-III.
  • Absence of contraindications to spinal anesthesia.
  • Absence of contraindications to performing a Pericapsular Nerve Group (PENG) block.
  • Absence of contraindications to the administration of the pharmacological agents utilized in the study.

You may not qualify if:

  • Absence of informed consent.
  • Age below 18 years.
  • Psychoactive substance abuse or dependence.
  • Chronic opioid therapy.
  • Contraindications to spinal anesthesia.
  • Contraindications to the Pericapsular Nerve Group (PENG) block.
  • Contraindications to the administration of study medications.
  • Body Mass Index (BMI) above 30 kg/m\^2.
  • Pregnancy.
  • History of chronic pain management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, SpinalAnalgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Radosław Owczuk, MD, PhD, Prof.

    Medical Unitersity of Gdansk

    STUDY CHAIR

Central Study Contacts

Mykhailo Kazantsev, MD

CONTACT

00 48 56 641 4039mykhailo.kazantsev@gmail.com

Study Design

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

Study Record Dates

First Submitted

February 5, 2026

First Posted

March 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share