Comparing Local Anesthetic Techniques for Clavicular Surgeries

NCT06220591 | Completed

• 1 other identifier: Clavicular anesthesia
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (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.

  24 hours

Secondary Outcomes (6)

• Onset of sensory block.

  20 minutes

• Ipsilateral diaphragmatic excursion affection.

  1 hour

• The Numerical Pain Rating Scale in the first 24 hours

  24 hours.

• The total opioid consumption in the first 24 hours

  24 hours.

• Patient and surgeon satisfaction.

  24 hours

Study Arms (2)

Superior trunk group

ACTIVE COMPARATOR

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

Clavipectoral fascial plane group

ACTIVE COMPARATOR

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

Interventions

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.

Superior trunk group

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.

Clavipectoral fascial plane group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

Location

Related Publications (6)

• 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.

  PMID: 12378163 BACKGROUND

• 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.

  PMID: 22248169 BACKGROUND

• 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.

  PMID: 31031496 BACKGROUND

• 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.

  PMID: 24747317 BACKGROUND

• 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.

  PMID: 31490292 BACKGROUND

• 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.

  PMID: 37692707 BACKGROUND

Study Officials

• Ahmed Mohamed Fahmy, MD

  Lecturer of Anesthesia, Intensive Care & Pain management, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

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 GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 24, 2024
• Study Start: January 27, 2024
• Primary Completion: July 28, 2024
• Study Completion: August 31, 2024
• Last Updated: September 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)