NCT07584200

Brief Summary

The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty. The main questions this study aims to answer are: Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone. Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation. The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.

Trial Health

63
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Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 13, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 13, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

March 13, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Total Postoperative Opioid Consumption

    Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.

    Up to 48 hours after surgery

Secondary Outcomes (12)

  • Pain scores at rest

    6 hours after surgery

  • Pain scores durring movement

    6 hours after surgery

  • Pain scores at rest

    12 hours after surgery

  • Pain scores durring movement

    12 hours after surgery

  • Pain scores at rest

    24 hours after surgery

  • +7 more secondary outcomes

Study Arms (3)

Spinal Anesthesia With Intrathecal Morphine

ACTIVE COMPARATOR

Participants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine. Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care.

Drug: Intrathecal Morphine

Spinal Anesthesia Plus PENG Block

EXPERIMENTAL

Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection.

Procedure: Pericapsular Nerve Group Block

Spinal Anesthesia Plus PENG Block With Dexamethasone

EXPERIMENTAL

Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection.

Drug: Dexamethasone

Interventions

Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.

Also known as: Morphine (intrathecal)
Spinal Anesthesia With Intrathecal Morphine

Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.

Also known as: PENG Block
Spinal Anesthesia Plus PENG Block

Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.

Also known as: Dexamethasone (perineural)
Spinal Anesthesia Plus PENG Block With Dexamethasone

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 60 to 100 years
  • Scheduled for elective total hip arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
  • Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
  • Infection at the site of spinal or peripheral nerve block injection
  • Pre-existing neurological disorders affecting sensory or motor function
  • Severe hepatic or renal insufficiency
  • Chronic opioid use for more than 3 months prior to surgery
  • Refusal or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

MorphineDexamethasone

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, Fluorinated

Study Officials

  • Malgorzata Reysner, MD PhD

    Poznań University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Malgorzata Reysenr, MD PhD

CONTACT

Malgorzata Reysner, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

May 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 13, 2026

Record last verified: 2026-02

Locations