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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/514/261/14 | Other Identifier | Health Sciences University Kartal Dr. Lutfi Kırdar City Hospital Ethics Committee Approval Number |
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Hip fractures are among the most common orthopedic traumas, particularly in elderly patients, and are usually associated with significant pain during positioning for spinal anesthesia. Adequate pain control during positioning can improve patient comfort and facilitate successful administration of anesthesia. The pericapsular nerve group (PENG) block has recently been introduced as a regional anesthesia technique that targets articular branches of the femoral, obturator, and accessory obturator nerves, and has been proposed as a method to reduce pain related to hip fracture positioning.
This study is designed to compare the efficacy of preoperative PENG block versus no block in patients undergoing proximal femoral nailing surgery under spinal anesthesia. The primary objective is to assess its effect on positioning pain using visual analog scale (VAS) scores. Secondary objectives include evaluating its impact on postoperative analgesic consumption, time to first rescue analgesic, and potential side effects.
This is a prospective, single-center, randomized controlled trial conducted at the University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital. A total of 60 patients, aged 18-90 years, with ASA I-III status, scheduled for proximal femoral nailing (PFN) surgery due to hip fracture, were enrolled. Patients were randomized into two groups using a sealed-envelope method:
PENG Block Group: Received a preoperative ultrasound-guided pericapsular nerve group (PENG) block 30 minutes before spinal anesthesia.
Control Group: Received no block prior to spinal anesthesia.
Standard spinal anesthesia was performed in both groups. All patients received intravenous paracetamol for postoperative analgesia at regular intervals. Additional analgesia with intravenous tramadol was administered if VAS ≥ 4.
The following parameters were collected:
Demographics (age, sex, BMI, ASA status, comorbidities)
Hemodynamic variables (SBP, DBP, HR, SpOâ‚‚) at baseline and during perioperative period
VAS scores at baseline, during positioning, and at postoperative time intervals (0, 15, 30 minutes, and 1, 2, 6, 12, and 24 hours)
Time to first rescue analgesic
Total opioid consumption in the first 24 hours postoperatively
Side effects such as nausea, vomiting, or other complications
The study aims to test the hypothesis that PENG block can reduce pain during positioning for spinal anesthesia and may improve postoperative analgesia in patients undergoing hip fracture surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENG Block Group | Experimental | Patients in this group received an ultrasound-guided Pericapsular Nerve Group (PENG) block prior to spinal anesthesia for hip fracture surgery. The block was performed with local anesthetic injection under ultrasound guidance, targeting the articular branches innervating the anterior hip capsule. |
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| Control Group | Active Comparator | Patients in this group did not receive a preoperative nerve block. They underwent spinal anesthesia directly for hip fracture surgery without prior intervention. Pain during positioning and postoperative analgesic requirements were evaluated in comparison to the PENG block group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericapsular nerve group (PENG) block | Procedure | A single-shot PENG block was administered preoperatively using ultrasound guidance. The block was performed with the patient in the supine position, and 20 mL of local anesthetic (0.25% bupivacaine) was injected between the psoas tendon and the superior pubic ramus to achieve analgesia of the anterior hip capsule. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity during positioning for spinal anesthesia | Pain scores were recorded using the Visual Analog Scale (VAS; 0-10 cm, where 0 = no pain and 10 = worst pain imaginable) during positioning for spinal anesthesia prior to hip fracture surgery. | During spinal anesthesia positioning (within 15 minutes preoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative VAS scores | Pain scores were assessed using the Visual Analog Scale (VAS) at 2, 6, 12, and 24 hours postoperatively. | 0-24 hours after surgery |
| Cumulative tramadol requirement in the first 24 hours |
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Inclusion Criteria:
Patients aged 18 to 90 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gulcan Gul, M.D. | Department of Anesthesiology and Reanimation, Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences, Istanbul, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facility Name: Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences | Istanbul | 34890 | Turkey (Türkiye) |
Plan Description: Individual participant data (IPD) will not be shared because this study was a single-center thesis project with a limited sample size. Only summary-level results and aggregate data will be published in peer-reviewed journals. Patient confidentiality and institutional data protection policies prevent public release of individual-level datasets.
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A randomized, parallel-group, controlled trial evaluating the effectiveness of PENG block versus no block in patients undergoing hip fracture surgery under spinal anesthesia.
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Participants and care providers were not blinded due to the nature of the intervention. However, the outcome assessor who recorded VAS scores and postoperative analgesic consumption was blinded to group assignment to reduce potential bias.
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| Standard Spinal Anesthesia (Control) | Procedure | Patients in this arm were managed according to standard care protocols for spinal anesthesia in hip fracture surgery. No preoperative regional block was performed. Pain scores and postoperative tramadol use were measured for comparison with the experimental arm. |
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The total dose of intravenous tramadol administered for breakthrough pain was recorded for each patient.
| 0-24 hours after surgery |
| Time to first request for rescue analgesia | The duration (in hours) between the end of surgery and the first administration of rescue tramadol was recorded. | 0-24 hours after surgery |
| Incidence of adverse events related to anesthesia | Frequency of side effects such as nausea, vomiting, hypotension, and local anesthetic systemic toxicity were documented. | Intraoperative to 24 hours postoperatively |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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