Hip Fracture
Conditions
Keywords
Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, Regional Anesthesia, Postoperative Analgesia, Spinal Anesthesia, Tramadol Consumption, QoR-15, Hip Fracture Surgery
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.
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
PROCEDUREQuadro-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.
PROCEDURESuprainguinal 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.
Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.
Sponsors
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to receive quadro-iliac plane block, suprainguinal fascia iliaca block, or standard analgesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Tramadol Consumption During the First 24 Postoperative Hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity at Rest | 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. |
| Time to First Rescue Analgesia | Within the first 24 hours after surgery | Time from completion of surgery to the first administration of rescue analgesia, measured in hours. |
| Rescue Analgesic Requirement | Within the first 24 hours after surgery | The proportion of patients requiring rescue analgesia during the first 24 hours after surgery. |
| Incidence of Postoperative Nausea and Vomiting | 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. |
| Quality of Recovery-15 (QoR-15) Score | 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. |
| Patient Satisfaction Score | 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. |
| Block-related Complications | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTmuzaffer Gencer
CONTACTkenan kart, md
PRINCIPAL_INVESTIGATORKenan Kart
Karabuk University
Outcome results
None listed