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Cervical Erector Spinae Plane Block in Proximal Humeral Fracture Surgery, A Motor-Sparing Block

ConditionsCervicalErector Spinae Plane BlockProximal Humeral Fracture Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMenoufia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical erector spinae plane block

    Drug

    Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.

  • General anesthesia

    Drug

    Patients will receive general anesthesia alone with no block.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Group ESPB (study group)Experimental treatment 1 intervention
Group B: Group C (Control group):Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Diaphragmatic excursion

Diaphragmatic excursion will be assessed using ultrasound.

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menoufia University

Lead sponsor

Source ClinicalTrials.gov
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