CervicalNCT07824466
Cervical Erector Spinae Plane Block in Proximal Humeral Fracture Surgery, A Motor-Sparing Block
A study testing Cervical erector spinae plane block and General anesthesia in people with Cervical and Erector Spinae Plane Block, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical, Erector Spinae Plane Block, Proximal Humeral Fracture Surgery
- What is being tested?
- Cervical erector spinae plane block and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Shibīn al Kawm, Menoufia, 32951
Ahmed E Elharty, MBBCH, 00201000262671, Ahmed.Alsyed55@med.menofia.edu.eg
Alaaeldin A Aiad, MD
About this study
Official title: Evaluation of Analgesic Efficacy of Cervical Erector Spinae Plane Block in Proximal Humeral Fracture Surgery, A Motor-Sparing Block
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.
Read the 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.
- Being tested
- Cervical erector spinae plane block, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical erector spinae plane blockDrug
Also called 20 mL bupivacaine 0.25%
Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia.
General anesthesiaDrug
Also called Propofol, fentanyl, and atracurium
Patients will receive general anesthesia alone with no block.
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB (study group) | Experimental | Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia. Receives: Drug: Cervical erector spinae plane block |
| Group C (Control group): | Active comparator | Patients will receive general anesthesia alone with no block. Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (7)
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)
Measured: 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.
Measured: 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.
Measured: 24 hours postoperatively
Diaphragmatic excursion
Diaphragmatic excursion will be assessed using ultrasound.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Aug 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alsyed, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824466
- Sponsor's protocol ID
- 7/2026 ANEST 69
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.