Comparing Local Anesthetic Techniques for Clavicular Surgeries

September 17, 2024 updated by: Zagazig University

Ultrasound-guided Selective Supraclavicular Nerve Block with Either Superior Trunk or Clavipectoral Fascial Plane Block for Clavicular Surgery

Surgical fixation for acute clavicular fractures is increasingly preferred among orthopedic surgeons to improve healing and decrease the risk of malunion. Regional anesthesia for clavicular fractures allows rapid recovery, prolonged postoperative analgesia, and less opioid consumption, and so decreases the hospital stay. There is no consensus regarding the best regional anesthetic technique for surgical fixation for acute clavicular fractures. Selective supraclavicular nerve block combined with either superior trunk or clavipectoral fascial plane block is a promising regional anesthetic technique for midshaft clavicular surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will assess if there is a difference in the quality of surgical anesthesia between selective supraclavicular nerve block combined with either superior trunk or clavipectoral fascial plane block for clavicular fractures. Aiming to achieve high-quality surgical anesthesia and postoperative analgesia for middle clavicular fracture surgeries with optimum hemodynamic stability and high patient and surgeon satisfaction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Egypt
    • Al-Sharkia
      • Zagazig, Al-Sharkia, Egypt, 44519
        • Zagazig University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18-45 years old.
  • Sex: both sexes.
  • The American Society of Anesthesiologists (ASA) Physical status: ASA I & II.
  • Body mass index (BMI): 18.5 - 24.9 kg/m2.
  • Type of operations: surgical repair of the midshaft clavicular injuries.

Exclusion Criteria:

  • Patient refusal.
  • Known hypersensitivity to lidocaine or bupivacaine.
  • Patients with respiratory insufficiency.
  • Coagulation disorders or taking drugs affect surgical hemostasis.
  • Patients with pre-existing neurological deficits
  • Uncooperative patient or with altered mental status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Superior trunk group
The patient will undergo selective supraclavicular nerve block, then will undergo block of superior trunk "The fifth & sixth cervical nerve roots" of the brachial plexus on the side of the affected clavicle.
Procedure: Superior trunk block
The patient will receive selective supraclavicular nerve block, then will undergo blockage of superior trunk "the fifth and sixth cervical nerves" of the brachial plexus. The operator will scan the supraclavicular nerve on the lateral border of the sternomastoid muscle. Local anesthetics mixture"3 cc" will be injected in 0.5 cc aliquots after negative aspiration to encircle the supraclavicular nerve. Then ultrasound probe will be moved to scan the superior trunk "the fifth and sixth cervical nerves" in the scalene groove.15 cc of local anesthetics mixture will be injected in 0.5 cc aliquots to encircle the fifth & sixth cervical nerve roots.
Active Comparator: Clavipectoral fascial plane group
The patient will undergo selective supraclavicular nerve block, then will undergo clavipectoral fascial plane block on the lateral and medial ends of the affected clavicle.
Procedure: Clavipectoral fascial plane block
The patient will receive selective supraclavicular nerve block, then will undergo clavipectoral fascial plane block. The operator will scan the supraclavicular nerve on the lateral border of the sternomastoid muscle. Local anesthetics mixture"3 cc" will be injected in 0.5 cc aliquots after negative aspiration to encircle the supraclavicular nerve. The ultrasound probe will scan both the medial & lateral ends of the clavicle. Then Local anesthetics mixture"15 cc" will be injected in 0.5 cc aliquots after negative aspiration between the periosteum of the clavicle and the clavipectoral fascia. The same technique will be conducted on both the lateral and medial ends of the affected clavicle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time of the first rescue analgesic request by the patient postoperative.
Time Frame: 24 hours
The patient will be asked to quantify postoperative pain using the visual analogue pain score as the following 0: no pain, and 10: maximum imaginable pain. Nalbuphine 4 mg will be administered intravenous as rescue analgesia if the visual analogue pain score ≥4. The time of the first rescue analgesic request will be recorded.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Onset of sensory block.
Time Frame: 20 minutes
From the end of block procedure to the of loss of pin prick sensation will be tested over the affected clavicle.
20 minutes
Ipsilateral diaphragmatic excursion affection.
Time Frame: 1 hour
Ipsilateral diaphragmatic excursion will be assessed by M-mode ultrasound.
1 hour
The Numerical Pain Rating Scale in the first 24 hours
Time Frame: 24 hours.
On a scale of 0-10, the patient will be asked to quantify postoperative pain as the following 0: no pain, and 10: maximum imaginable pain.
24 hours.
The total opioid consumption in the first 24 hours
Time Frame: 24 hours.
The total dose of intravenous nalbuphine in the first 24 hours postoperatively
24 hours.
Patient and surgeon satisfaction.
Time Frame: 24 hours
Patient and surgeon satisfaction will be assessed using 7- point Likert-like verbal rating scale.
24 hours
Any reported complications.
Time Frame: 24 hours.
The possible side effects will be followed in the first 24 hours postoperative.
24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmed Mohamed Fahmy, MD, Lecturer of Anesthesia, Intensive Care & Pain management, Faculty of Medicine, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Clavicular anesthesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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