NCT07676734

Brief Summary

Hip fracture surgery is associated with significant postoperative pain and increased opioid requirements. Regional anesthesia techniques may improve analgesia and reduce opioid consumption. This prospective, randomized, double-blind, controlled trial aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. The primary outcome is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcome measures include postoperative pain intensity, rescue analgesic requirement, incidence of postoperative nausea and vomiting, Quality of Recovery-15 (QoR-15) score, and patient satisfaction score.

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
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

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

Study Progress9%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 23, 2026

Last Update Submit

June 27, 2026

Conditions

Keywords

Quadro-Iliac Plane BlockSuprainguinal Fascia Iliaca BlockRegional AnesthesiaPostoperative AnalgesiaSpinal AnesthesiaTramadol ConsumptionQoR-15Hip Fracture Surgery

Outcome Measures

Primary Outcomes (1)

  • Cumulative Tramadol Consumption During the First 24 Postoperative Hours

    The total amount of tramadol administered during the first 24 postoperative hours will be recorded and compared among the study groups.

    24 hours after surgery

Secondary Outcomes (7)

  • Postoperative Pain Intensity at Rest

    At 0, 2, 6, 12, and 24 hours after surgery

  • Time to First Rescue Analgesia

    Within the first 24 hours after surgery

  • Rescue Analgesic Requirement

    Within the first 24 hours after surgery

  • Incidence of Postoperative Nausea and Vomiting

    Within the first 24 hours after surgery

  • Quality of Recovery-15 (QoR-15) Score

    24 hours after surgery

  • +2 more secondary outcomes

Study Arms (3)

Quadro-Iliac Plane Block Group

EXPERIMENTAL

Patients assigned to this group will receive ultrasound-guided quadro-iliac plane block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia.

Procedure: Quadro-Iliac Plane Block

Suprainguinal Fascia Iliaca Block Group

EXPERIMENTAL

Patients assigned to this group will receive ultrasound-guided suprainguinal fascia iliaca block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia.

Procedure: Suprainguinal Fascia Iliaca Block

Standard Analgesia Group

ACTIVE COMPARATOR

Patients assigned to this group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.

Other: Standard Multimodal Analgesia

Interventions

Ultrasound-guided quadro-iliac plane block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.

Quadro-Iliac Plane Block Group

Ultrasound-guided suprainguinal fascia iliaca block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.

Suprainguinal Fascia Iliaca Block Group

Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.

Standard Analgesia Group

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged 18 years or older
  • Patients scheduled for hip fracture surgery under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Provision of written informed consent

You may not qualify if:

  • Refusal to participate
  • Contraindications to spinal anesthesia
  • Contraindications to regional anesthesia
  • Allergy to local anesthetics or study medications
  • Infection at the injection site
  • Coagulopathy or anticoagulant therapy precluding regional block
  • Cognitive impairment preventing pain assessment
  • Chronic opioid use
  • Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Kenan Kart

    Karabuk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, outcome assessors, and investigators involved in postoperative data collection and statistical analysis will be blinded to group allocation. The anesthesiologist performing the block procedures will not participate in postoperative assessments or data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1:1 ratio to receive quadro-iliac plane block, suprainguinal fascia iliaca block, or standard analgesia.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 30, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data will not be made publicly available.

Locations