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| ID | Type | Description | Link |
|---|---|---|---|
| 105 | Other Identifier | Ä°stanbul Medipol University Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadro-Iliac Plane Block Group | Experimental | 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. |
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| Suprainguinal Fascia Iliaca Block Group | Experimental | 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. |
|
| Standard Analgesia Group | Active Comparator | Patients assigned to this group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| muzaffer Gencer | Contact | +905059436459 | dr.m.gencer07@gmail.com | |
| kenan kart, md | Contact | 5063849983 | kenankart@karabuk.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Kenan Kart | Karabuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başakşehir Çam and Sakura City Hospital | Istanbul | Istanbul | Turkey (Türkiye) |
De-identified individual participant data will not be made publicly available.
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Participants will be randomly assigned in a 1:1:1 ratio to receive quadro-iliac plane block, suprainguinal fascia iliaca block, or standard analgesia.
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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.
| 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. |
|
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. |
| D007869 |
| Leg Injuries |