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NCT Number: NCT07676734

Comparison of Three Analgesic Strategies for Hip Fracture Surgery

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.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadro-Iliac Plane Block

Procedure

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.

suprainguinal fascia iliaca block

Procedure

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.

Standard Multimodal Analgesia

Other

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

Primary outcomes

  1. Cumulative Tramadol Consumption During the First 24 Postoperative Hours

    Time frame: 24 hours after surgery

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

Secondary outcomes

  1. Postoperative Pain Intensity at Rest

    Time frame: At 0, 2, 6, 12, and 24 hours after surgery

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

  2. Time to First Rescue Analgesia

    Time frame: Within the first 24 hours after surgery

    Time from completion of surgery to the first administration of rescue analgesia, measured in hours.

  3. Rescue Analgesic Requirement

    Time frame: Within the first 24 hours after surgery

    The proportion of patients requiring rescue analgesia during the first 24 hours after surgery.

  4. Incidence of Postoperative Nausea and Vomiting

    Time frame: Within the first 24 hours after surgery

    The incidence of postoperative nausea and/or vomiting during the first 24 hours after surgery will be recorded.

  5. Quality of Recovery-15 (QoR-15) Score

    Time frame: 24 hours after surgery

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

  6. Patient Satisfaction Score

    Time frame: 24 hours after surgery

    Patient satisfaction with postoperative pain management will be assessed using a numerical rating scale scored between 0 and 10 at postoperative 24 hours (0 = not satisfied at all, 10 = completely satisfied). Higher scores indicate greater patient satisfaction.

  7. Block-related Complications

    Time frame: During the first 24 hours after surgery.

    The incidence of block-related complications, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, and persistent sensory or motor deficits, will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

kenan kart, md

CONTACT

[email protected]

5063849983

muzaffer Gencer

CONTACT

[email protected]

+905059436459

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study 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

Acronym: HIP-3B

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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