Cervical, Erector Spinae Plane Block, Proximal Humeral Fracture Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.
DRUGGeneral anesthesia
Patients will receive general anesthesia alone with no block.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-70 years old. * Adults scheduled for unilateral proximal humerus open reduction and internal fixation (ORIF). * American Society of Anesthesiologists (ASA) physical status I-II patients.
Exclusion criteria
* Patient refusal. * Coagulopathy \[International Normalized Ratio (INR) \>1.4, platelets \<100,000/mm³\]. * Local infection at the block site. * Allergy to local anesthetics or opioids. * History of drug addiction or chronic opioid use. * Significant neurological or psychiatric disorders. * Hemodynamically unstable patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fentanyl consumption | 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) |
| Total amount of nalbuphine consumption | 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 to the 1st rescue analgesia | 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. |
| Diaphragmatic excursion | Intraoperatively | Diaphragmatic excursion will be assessed using ultrasound. |
| Mean arterial pressure | 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. |
| Heart rate | 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. |
| Incidence of complications | 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. |
Countries
Egypt
Contacts
CONTACTAhmed E Elharty, MBBCH
Outcome results
None listed