Comparison of Three Analgesic Strategies for Hip Fracture Surgery
ConditionHip Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBaşakşehir Çam & Sakura City Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to participate
Contraindications to spinal anesthesia
Contraindications to regional anesthesia
Allergy to local anesthetics or study medications
Trial design
Design model
Parallel
Treatments tested in this trial
Quadro-Iliac Plane Block
Procedure/SurgeryUltrasound-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/SurgeryUltrasound-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 interventionPatients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Quadro-Iliac Plane Block GroupExperimental treatment 1 intervention
Group B: Suprainguinal Fascia Iliaca Block GroupExperimental treatment 1 intervention
Group C: Standard Analgesia GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
24 hours after surgerySecondary outcomes
1
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.
Time frame
At 0, 2, 6, 12, and 24 hours after surgery2
Time to First Rescue Analgesia
Time from completion of surgery to the first administration of rescue analgesia, measured in hours.
Time frame
Within the first 24 hours after surgery3
Rescue Analgesic Requirement
The proportion of patients requiring rescue analgesia during the first 24 hours after surgery.
Time frame
Within the first 24 hours after surgery4
Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and/or vomiting during the first 24 hours after surgery will be recorded.
Time frame
Within the first 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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