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Completed

NCT Number: NCT06220591

Comparing Local Anesthetic Techniques for Clavicular Surgeries

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.

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Key information

Conditions

Anesthesia, Local

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Superior trunk block

Procedure

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 block

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Ipsilateral diaphragmatic excursion affection.

    Time frame: 1 hour

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

  3. 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.

  4. 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

  5. Patient and surgeon satisfaction.

    Time frame: 24 hours

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

  6. Any reported complications.

    Time frame: 24 hours.

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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