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Anesthesia, LocalNCT06220591

Comparing Local Anesthetic Techniques for Clavicular Surgeries

A study testing Superior trunk block and Clavipectoral fascial plane block in people with Anesthesia, Local, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Anesthesia, Local
What is being tested?
Superior trunk block and Clavipectoral fascial plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteEgypt
Study dates
27 Jan 2024to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Zagazig university hospital

    Zagazig, Al-Sharkia, 44519

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Superior trunk block, Clavipectoral fascial plane block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Superior trunk blockProcedure or surgery

    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.

  • Clavipectoral fascial plane blockProcedure or surgery

    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.

Study groups in NCT06220591
Study groupRoleWhat they receive
Superior trunk groupActive comparatorThe 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.
Receives: Procedure: Superior trunk block
Clavipectoral fascial plane groupActive comparatorThe patient will undergo selective supraclavicular nerve block, then will undergo clavipectoral fascial plane block on the lateral and medial ends of the affected clavicle.
Receives: Procedure: Clavipectoral fascial plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of the first rescue analgesic request by the patient postoperative.

    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.

    Measured: 24 hours

Secondary outcomes (6)

  1. Onset of sensory block.

    From the end of block procedure to the of loss of pin prick sensation will be tested over the affected clavicle.

    Measured: 20 minutes

  2. Ipsilateral diaphragmatic excursion affection.

    Ipsilateral diaphragmatic excursion will be assessed by M-mode ultrasound.

    Measured: 1 hour

  3. The Numerical Pain Rating Scale in the first 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.

    Measured: 24 hours.

  4. The total opioid consumption in the first 24 hours

    The total dose of intravenous nalbuphine in the first 24 hours postoperatively

    Measured: 24 hours.

  5. Patient and surgeon satisfaction.

    Patient and surgeon satisfaction will be assessed using 7- point Likert-like verbal rating scale.

    Measured: 24 hours

  6. Any reported complications.

    The possible side effects will be followed in the first 24 hours postoperative.

    Measured: 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start27 Jan 2024
  3. Primary completion28 Jul 2024
  4. Study completion31 Aug 2024

Resources

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220591
Sponsor's protocol ID
Clavicular anesthesia
Status last verified
Dec 2023
First submitted
27 Dec 2023
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Postacchini F, Gumina S, De Santis P, Albo F. Epidemiology of clavicle fractures. J Shoulder Elbow Surg. 2002 Sep-Oct;11(5):452-6. doi: 10.1067/mse.2002.126613.

    PubMed 12378163

  • Virtanen KJ, Malmivaara AO, Remes VM, Paavola MP. Operative and nonoperative treatment of clavicle fractures in adults. Acta Orthop. 2012 Feb;83(1):65-73. doi: 10.3109/17453674.2011.652884. Epub 2012 Jan 17.

    PubMed 22248169

  • Banerjee S, Acharya R, Sriramka B. Ultrasound-Guided Inter-scalene Brachial Plexus Block with Superficial Cervical Plexus Block Compared with General Anesthesia in Patients Undergoing Clavicular Surgery: A Comparative Analysis. Anesth Essays Res. 2019 Jan-Mar;13(1):149-154. doi: 10.4103/aer.AER_185_18.

    PubMed 31031496

  • Valdes-Vilches LF, Sanchez-del Aguila MJ. Anesthesia for clavicular fracture: selective supraclavicular nerve block is the key. Reg Anesth Pain Med. 2014 May-Jun;39(3):258-9. doi: 10.1097/AAP.0000000000000057. No abstract available.

    PubMed 24747317

  • Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.

    PubMed 31490292

  • Goncalves D, Sousa CP, Graca R, Miguelez MP, Sampaio C. Clavipectoral Fascia Plane Block Combined With Superficial Cervical Plexus Block for the Removal of Osteosynthesis Material From Clavicle Fracture. Cureus. 2023 Aug 8;15(8):e43146. doi: 10.7759/cureus.43146. eCollection 2023 Aug.

    PubMed 37692707

Questions about this trial

What is this clinical trial studying?

A study testing Superior trunk block and Clavipectoral fascial plane block in people with Anesthesia, Local, run by Zagazig 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 20 Sep 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of the first rescue analgesic request by the patient postoperative. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220591, which also lists 6 linked publications.

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 20 Sep 2024.

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