NCT07631091

Brief Summary

This study aims to determine whether isobaric ropivacaine is more suitable than isobaric bupivacaine for spinal anesthesia in outpatient total hip arthroplasty (THA). The study will evaluate whether ropivacaine allows faster recovery of sensory and motor function while still providing adequate surgical anesthesia and postoperative pain control. Additional aims are to assess the effects of the anesthetic technique on same-day discharge rates, postoperative recovery, urinary retention, opioid consumption, and patient satisfaction after outpatient THA.

Trial Health

65
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Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for phase_4

Timeline
23mo left

Started Jun 2026

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 Progress2%
Jun 2026May 2028

First Submitted

Initial submission to the registry

May 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

May 7, 2026

Last Update Submit

June 2, 2026

Conditions

Hip OsteoarthritisHip Arthroplasty ReplacementPostoperative Pain After Ambulatory Surgery

Outcome Measures

Primary Outcomes (1)

  • Return of Sensory and Motor Function

    24 hours

Secondary Outcomes (10)

  • Numeric Rating Scale (NRS) for Postoperative Pain

    24 hours

  • Urinary retention

    24 hours

  • Post-operative nausea and vomiting

    24 hours

  • Postoperative opioid consumption in morphine milligram equivalents (MME)

    24 hours

  • 5-Point Likert Satisfaction Scale

    24 hours

  • +5 more secondary outcomes

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

Patients receive spinal anesthesia with intrathecal ropivacaine

Drug: Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml)

Bupivacaine

ACTIVE COMPARATOR

Patients receive spinal anesthesia with intrathecal bupivacaine

Drug: Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)

Interventions

Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml)DRUG

Patients receive spinal anesthesia with intrathecal ropivacaine

Ropivacaine
Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)DRUG

Patients receive spinal anesthesia with intrathecal bupivacaine

Bupivacaine

Eligibility Criteria

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

You may qualify if:

  • years of age
  • Scheduled for a primary elective total hip arthroplasty
  • Patient must be a candidate for same day discharge
  • Informed consent understood and signed
  • Patient is 160 - 186 cm tall

You may not qualify if:

  • Scheduled bilateral THA
  • Contraindication to or failed spinal anesthesia
  • Allergy or contraindication to NSAIDs (e.g. chronic kidney disease)
  • Diabetes requiring insulin medication
  • Preoperative chronic use of illegal substances
  • Renal insufficiency (eGFR \< 60)
  • Unstable psychiatric conditions
  • Severe neurological disorder
  • Cognitive deficiencies preventing informed consent
  • Language barrier preventing completion of study
  • Pregnancy or breastfeeding
  • Chronic pain syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Anesthesia, SpinalRopivacaineBupivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Panu Uusalo, MD, PhD

    University of Turku and Turku University Hospital, Finland

    STUDY DIRECTOR

Central Study Contacts

Panu Uusalo, MD, PhD

CONTACT

+35823133077panu.uusalo@varha.fi

Maarit Rantakokko, MD

CONTACT

maarit.rantakokko@varha.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Adjunct Professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

June 5, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study data contain sensitive personal health information collected from a relatively small patient population at a single study center. Due to the limited sample size and detailed clinical information, there is a risk that participants could be indirectly identifiable even after de-identification. Data sharing is therefore restricted in order to protect participant privacy and confidentiality in accordance with applicable data protection legislation, institutional policies, and the informed consent provided by study participants.