NCT Number: NCT07824466
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Shibīn al Kawm, Menoufia, 32951, Egypt
Location status: Recruiting
Ahmed E Elharty, MBBCH
CONTACT
Alaaeldin A Aiad, MD
SUB_INVESTIGATOR
Amany S Abdel Haleem, MD
SUB_INVESTIGATOR
Asmaa E Salama, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.
Other names: 20 mL bupivacaine 0.25%
Patients will receive general anesthesia alone with no block.
Other names: Propofol, fentanyl, and atracurium
Time frame: 24 hours postoperatively
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: Intraoperatively
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: 24 hours postoperatively
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 first request for the rescue analgesia will be recorded from end of surgery to first dose of nalbuphine administered.
Time frame: Intraoperatively
Diaphragmatic excursion will be assessed using ultrasound.
Time frame: 12 hours postoperatively
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 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: 24 hours postoperatively
Incidence of complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
Contact information is provided by the study sponsor or research team.
Menoufia University
Other
Evaluation of Analgesic Efficacy of Cervical Erector Spinae Plane Block in Proximal Humeral Fracture Surgery, A Motor-Sparing Block
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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