An interventional study of Cervical erector spinae plane block and General anesthesia in Cervical, Erector Spinae Plane Block and Proximal Humeral Fracture Surgery, sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
This study aims to evaluate the efficacy of cervical erector spinae plane block (ESPB) in managing postoperative pain following proximal humerus fracture repair in patients receiving general anesthesia.
Proximal humeral fracture (PHF) is among the most common fractures in the elderly, particularly in women. Postoperative pain following surgical repair of PHF represents a significant clinical challenge. It directly impacts the patient's recovery, adherence to rehabilitation, and long-term functional outcomes.
The erector spinae plane block (ESPB) is a relatively novel regional anesthesia technique that has gained popularity due to its simplicity, safety profile, and broad applicability.
The resulting multi-dermatomal sensory block covers the anterior, lateral, and posterior thoracic and abdominal walls. This widespread effect is attributed to cranial and caudal spread of the anesthetic, facilitated by the thoracolumbar fascia. Radiologic studies have demonstrated anesthetic spread extending across three to four vertebral levels from the injection site.
113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.
This study's planned enrollment of 44 is below the median of 70 across 50 interventional studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.
Drug: Cervical erector spinae plane block
Patients will receive general anesthesia alone with no block.
Drug: General anesthesia
Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.
Also known as: 20 mL bupivacaine 0.25%
Patients will receive general anesthesia alone with no block.
Also known as: Propofol, fentanyl, and atracurium
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 4, 8, 12, 18, and 24 h after surgery.
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Top-up doses of fentanyl 0.5 μg/kg will be given if hemodynamics increase above 20% of preoperative baseline values, and can be repeated if there is no improvement after 10 minutes (maximum dose is 2 μg/kg for the whole procedure)
Time frame: Intraoperatively
Total amount of nalbuphine consumption
Rescue analgesia will be provided with intravenous nalbuphine 0.1 mg/kg when visual analog scale (VAS) is ≥4, which may be repeated after 30 minutes if pain persists (maximum total dose of 20 mg/6 hours), with appropriate monitoring.
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of nalbuphine administered.
Time frame: 24 hours postoperatively
Diaphragmatic excursion
Diaphragmatic excursion will be assessed using ultrasound.
Time frame: Intraoperatively
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery, at post-anesthetic care unit (PACU) admission, then at 2, 4, 8, and 12 hours postoperatively.
Time frame: 12 hours postoperatively
Heart rate
Heart rate will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery, at post-anesthetic care unit (PACU) admission, then at 2, 4, 8, and 12 hours postoperatively.
Time frame: 12 hours postoperatively
Incidence of complications
Incidence of complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
Time frame: 24 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
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