NCT07824466

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Aug 2026Jul 2027

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 9, 2026

Last Update Submit

September 16, 2026

Conditions

CervicalProximal Humeral Fracture SurgeryErector Spinae Plane Block

Outcome Measures

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.

    24 hours postoperatively

Secondary Outcomes (7)

  • Intraoperative fentanyl consumption

    Intraoperatively

  • Total amount of nalbuphine consumption

    24 hours postoperatively

  • Time to the 1st rescue analgesia

    24 hours postoperatively

  • Diaphragmatic excursion

    Intraoperatively

  • Mean arterial pressure

    12 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Group ESPB (study group)

EXPERIMENTAL

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

Drug: Cervical erector spinae plane block

Group C (Control group):

ACTIVE COMPARATOR

Patients will receive general anesthesia alone with no block.

Drug: General anesthesia

Interventions

Cervical erector spinae plane blockDRUG

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

Also known as: 20 mL bupivacaine 0.25%
Group ESPB (study group)
General anesthesiaDRUG

Patients will receive general anesthesia alone with no block.

Also known as: Propofol, fentanyl, and atracurium
Group C (Control group):

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32951, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, GeneralPropofolFentanylAtracurium

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Ahmed E Elharty, MBBCH

CONTACT

00201000262671Ahmed.Alsyed55@med.menofia.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University, Egypt

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)