Comparison of Three Analgesic Strategies for Hip Fracture Surgery (HIP-3B)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fracture
• Intervention / Treatment: Procedure: Quadro-Iliac Plane Block; Procedure: Suprainguinal Fascia Iliaca Block; Other: Standard Multimodal Analgesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: muzaffer Gencer; Phone Number: +905059436459; Email: dr.m.gencer07@gmail.com
• Study Contact Backup: Name: kenan kart, md; Phone Number: 5063849983; Email: kenankart@karabuk.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye)
      • Başakşehir Çam and Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadro-Iliac Plane Block Group; 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; 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.
Experimental: Suprainguinal Fascia Iliaca Block Group; 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; 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.
Active Comparator: Standard Analgesia Group; 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; Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity at Rest	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.	At 0, 2, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesia	Time from completion of surgery to the first administration of rescue analgesia, measured in hours.	Within the first 24 hours after surgery
Rescue Analgesic Requirement	The proportion of patients requiring rescue analgesia during the first 24 hours after surgery.	Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting	The incidence of postoperative nausea and/or vomiting during the first 24 hours after surgery will be recorded.	Within the first 24 hours after surgery
Quality of Recovery-15 (QoR-15) Score	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.	24 hours after surgery
Patient Satisfaction Score	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.	24 hours after surgery
Block-related Complications	The incidence of block-related complications, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, and persistent sensory or motor deficits, will be recorded.	During the first 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Investigators: Principal Investigator: Kenan Kart, Karabuk University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Hip Fracture Surgery; Spinal Anesthesia; Postoperative Analgesia; QoR-15; Suprainguinal Fascia Iliaca Block; Quadro-Iliac Plane Block; Tramadol Consumption
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: HIP-QIPB-SIFIB-2026; 105 (Other Identifier: İstanbul Medipol University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data will not be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No