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Not yet recruiting NCT07676734

Comparison of Three Analgesic Strategies for Hip Fracture Surgery

No phase Interventional Hip Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, Standard Multimodal Analgesia.
Who it may be relevant to
Registry conditions: Hip Fracture. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Postoperative Analgesic Efficacy of Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, and Standard Analgesia Protocol in Patients Undergoing Hip Fracture Surgery Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind, Controlled Trial

Overview

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.

Detailed description

Hip fracture surgery is frequently associated with severe postoperative pain, delayed mobilization, and increased opioid consumption. Regional anesthesia techniques have been increasingly used to improve postoperative analgesia and reduce opioid-related adverse effects.

This prospective, randomized, double-blind, controlled, multicenter study 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. Patients will be randomly allocated in a 1:1:1 ratio to one of the three study groups.

All surgical procedures will be performed under spinal anesthesia. Patients assigned to the QIPB group will receive ultrasound-guided quadro-iliac plane block, whereas patients assigned to the SIFIB group will receive ultrasound-guided suprainguinal fascia iliaca block. Patients in the control group will receive standard multimodal analgesia without a regional block.

The primary outcome measure is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, quality of recovery assessed with the Quality of Recovery-15 (QoR-15) questionnaire, patient satisfaction, intraoperative opioid consumption, and block-related complications.

The study is planned to enroll 90 patients across three centers.

Interventions

  • Procedure Quadro-Iliac Plane Block
    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.
  • Procedure Suprainguinal Fascia Iliaca Block
    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.
  • Other Standard Multimodal Analgesia
    Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.

Primary outcome measures

  • Cumulative Tramadol Consumption During the First 24 Postoperative Hours [Time frame: 24 hours after surgery]
Secondary outcome measures (7)
  • Postoperative Pain Intensity at Rest [Time frame: At 0, 2, 6, 12, and 24 hours after surgery]
  • Time to First Rescue Analgesia [Time frame: Within the first 24 hours after surgery]
  • Rescue Analgesic Requirement [Time frame: Within the first 24 hours after surgery]
  • Incidence of Postoperative Nausea and Vomiting [Time frame: Within the first 24 hours after surgery]
  • Quality of Recovery-15 (QoR-15) Score [Time frame: 24 hours after surgery]
  • Patient Satisfaction Score [Time frame: 24 hours after surgery]
  • Block-related Complications [Time frame: During the first 24 hours after surgery.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Başakşehir Çam and Sakura City Hospital — Istanbul

Identifiers

NCT: NCT07676734 · HIP-QIPB-SIFIB-2026 · 105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗