NCT06831604

Brief Summary

This study aims to evaluate and compare the efficacy and safety of ultrasound guided superficial cervical plexus block (SCPB) with either clavipectoral fascial plane block (CPB) or interscalene brachial plexus block (ISBP) as an anesthetic technique for clavicle surgeries.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Feb 2025

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 Progress89%
Feb 2025Jul 2026

First Submitted

Initial submission to the registry

February 8, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

February 8, 2025

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success rate

    The block will be considered successful when complete sensory block is achieved within 45 min after injection of the study drug and inadequate block will be converted to general anesthesia and excluded from the study.

    Intraoperatively

Secondary Outcomes (4)

  • First request of the rescue analgesia

    24 hours postoperatively

  • Total morphine consumption

    24 hours postoperatively

  • Degree of patient satisfaction

    24 hours postoperatively

  • Incidence of Complications

    24 hours postoperatively

Study Arms (2)

Group I

EXPERIMENTAL

Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB).

Drug: Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB)

Group II

EXPERIMENTAL

Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP).

Drug: Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)

Interventions

Patients will receive Superficial Cervical Plexus Block (SCPB) and Clavipectoral Fascial Plane Block (CPB).

Also known as: Group I
Group I

Patients will receive Superficial Cervical Plexus Block (SCPB) and Interscalene Brachial Block (ISBP)

Also known as: Group II
Group II

Eligibility Criteria

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

You may qualify if:

  • Aged 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I, II.
  • Patients with unilateral clavicular fractures undergo elective internal fixation of clavicle fractures.

You may not qualify if:

  • Coagulopathy.
  • Patients with infection at block site.
  • Allergy to local anesthetics.
  • Patient with morbid obesity (body mass index \>35 kg/m2).
  • Pre-existing neurological disease.
  • Difficult communication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

small cardioactive peptide B

Central Study Contacts

Ahmed M Aboeldahab, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 18, 2025

Study Start

February 20, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

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