NCT07458360

Brief Summary

This prospective randomized controlled trial evaluates the effect of ultrasound-guided unilateral Femoral Rami and Obturator Nerve Trunk (FRONT) block on postoperative quality of recovery in patients undergoing elective total hip arthroplasty.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

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 Progress18%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

March 3, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Quality of Recovery (QoR-15 Score)

    Postoperative quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery.

    24 hours after surgery

Secondary Outcomes (6)

  • Quality of Recovery (QoR-15) Score at 48 Hours

    48 hours after surgery

  • Postoperative Pain Intensity

    2, 6, 12, 24, and 48 hours after surgery

  • Total Opioid Consumption

    0-24 hours after surgery

  • Time to First Rescue Analgesia

    Within the first 24 hours after surgery

  • Time to First Mobilization

    Within the first 48 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

FRONT Block Group

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided unilateral Femoral Rami and Obturator Nerve Trunk (FRONT) block in addition to standardized multimodal postoperative analgesia.

Procedure: FRONT Block (Femoral Rami and Obturator Nerve Trunk Block)Procedure: Standard Multimodal Analgesia

Control Group

ACTIVE COMPARATOR

Participants in this group will receive standardized multimodal postoperative analgesia without FRONT block.

Procedure: Standard Multimodal Analgesia

Interventions

Ultrasound-guided unilateral FRONT block targeting the femoral rami and obturator nerve trunk will be performed

FRONT Block Group

Standardized postoperative multimodal analgesia including intravenous paracetamol, nonsteroidal anti-inflammatory drugs, and rescue opioid analgesia as required.

Control GroupFRONT Block Group

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Scheduled for total hip arthroplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand and complete the QoR-15 questionnaire
  • Provided written informed consent

You may not qualify if:

  • Refusal to participate
  • Contraindication to spinal anesthesia or regional block
  • Allergy to study medications
  • Chronic opioid use (daily use for more than 3 months)
  • Neurological or neuromuscular disorders affecting the lower extremities
  • Infection at the injection site
  • Coagulation disorders
  • Cognitive impairment prevents questionnaire completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, HipPain, Postoperative

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by independent researchers blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to receive either an ultrasound-guided unilateral FRONT block plus standard multimodal analgesia or standard multimodal analgesia alone. Outcomes will be compared between the two parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

April 25, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

July 5, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations