About this trial
This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. Both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication.
A total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a Pericapsular Nerve Group (PENG) block or a femoral nerve block before the procedure. The study will monitor patients' pain scores using the Visual Analog Scale (VAS) at multiple time points, including during positioning and throughout the first 24 hours after surgery. It also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Scheduled for proximal femur fracture fixation under spinal anesthesia
Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
Ability to understand and use the Visual Analog Scale (VAS)
Disqualifiers
Coagulopathy
Local infection at the injection site
Known allergy to local anesthetics or magnesium sulfate
Severe cardiopulmonary disease [American Society of Anesthesiologists (ASA) ≥ IV]
Trial design
Parallel
Treatments tested in this trial
Pericapsular Nerve Group (PENG) Block
Procedure/SurgeryAssigned Interventions: Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus. Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analgesic efficacy of the block.
Femoral Nerve Block (FNB)
Procedure/SurgeryAn ultrasound-guided nerve block targeting the femoral nerve to provide analgesia before spinal anesthesia in proximal femur fracture surgery. Administered using 30 ml of 0.25% bupivacaine and 5 ml of 10% magnesium sulfate (500 mg). The block is performed with an in-plane ultrasound approach, identifying the femoral nerve lateral to the femoral artery under sterile conditions.
Treatment groups
Trial outcomes
Primary outcomes
Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used to assess pain intensity during positioning for spinal anesthesia. The VAS is a 10 cm line where 0 indicates no pain and 10 indicates the worst imaginable pain. The score will be recorded immediately before spinal anesthesia after performing either the PENG block or femoral nerve block.
Time to First Rescue Analgesia
The time (in hours) from the end of the nerve block to the first request for additional analgesia (nalbuphine 0.2 mg/kg IV) will be recorded for each patient.
Secondary outcomes
Total Nalbuphine Consumption
The cumulative dose (in mg) of intravenous nalbuphine administered for pain control will be calculated for each participant over the first 24 hours following surgery.
Mean Arterial Pressure (MAP) Changes
Mean arterial pressure will be recorded at baseline (pre-block), then at 2, 5, 10, 15 minutes post-block, and subsequently at 2, 6, 12, 18, and 24 hours after surgery to evaluate hemodynamic stability following either pericapsular nerve block (PENG) block or femoral nerve block.
Patient Satisfaction Score
Patient satisfaction with pain control will be evaluated using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at the end of the 24-hour postoperative period.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: