NCT06870071

Brief Summary

Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

March 5, 2025

Last Update Submit

April 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Quality of Recovery-15

    The primary outcome was the Quality of Recovery-15 score at 24 hours postoperatively. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery quality.

    24 hours

Study Arms (2)

control group

ACTIVE COMPARATOR

IV paracetamol (1 g, 3×1) and IV dexketoprofen (50 mg, 2×1)

Other: Quadro iliac plane block

Quadro iliac plane block

ACTIVE COMPARATOR

40 mL of 0.25% bupivacaine

Other: Control group

Interventions

IV paracetamol (1 g, 3×1) and IV dexketoprofen (50 mg, 2×1)

Quadro iliac plane block

40 mL of 0.25% bupivacaine

control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral THA.
  • Spinal anesthesia.
  • Age 18-85 years.
  • ASA classification I-IV.

You may not qualify if:

  • Patients who declined consent.
  • Contraindications to regional anesthesia.
  • Coagulation disorders.
  • Infections at the block site.
  • Emergency surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
PRINCIPAL INVESTIGATOR
PI Title
Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

March 11, 2025

Primary Completion

April 25, 2025

Study Completion

April 25, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations