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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesic Efficacy of Cervical Erector Spinae Plane Block in Proximal Humeral Fracture Surgery, A Motor-Sparing Block
- ClinicalTrials.gov ID
- NCT07824466
- Acronym / sponsor ID
- 7/2026 ANEST 69
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESPB (study group) | Experimental | Drug: Cervical erector spinae plane blockPatients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia. |
| Group C (Control group): | Active comparator | Drug: General anesthesiaPatients will receive general anesthesia alone with no block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical erector spinae plane blockAlso: 20 mL bupivacaine 0.25%Patients will receive cervical erector spinae plane block (ESPB) after the induction of general anesthesia. | Drug | Group ESPB (study group) |
| General anesthesiaAlso: Propofol, fentanyl, and atracuriumPatients will receive general anesthesia alone with no block. | Drug | Group C (Control group): |
Primary outcome
Degree of pain
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.
7 secondary outcomes
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Total amount of nalbuphine consumption
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Diaphragmatic excursion
Time frame: Intraoperatively
Mean arterial pressure
Time frame: 12 hours postoperatively
Heart rate
Time frame: 12 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed E Elharty, MBBCH (00201000262671, Ahmed.Alsyed55@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.