Clinical trial NCT06220591: Comparing Local Anesthetic Techniques for Clavicular Surgeries
Official title: Ultrasound-guided Selective Supraclavicular Nerve Block with Either Superior Trunk or Clavipectoral Fascial Plane Block for Clavicular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-01-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time of the first rescue analgesic request by the patient postoperative.
timeFrame: 24 hours
Secondary outcomes:
measure: Onset of sensory block.
timeFrame: 20 minutes
measure: Ipsilateral diaphragmatic excursion affection.
timeFrame: 1 hour
measure: The Numerical Pain Rating Scale in the first 24 hours
timeFrame: 24 hours.
measure: The total opioid consumption in the first 24 hours
timeFrame: 24 hours.
measure: Patient and surgeon satisfaction.
timeFrame: 24 hours
measure: Any reported complications.
timeFrame: 24 hours.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university hospital
state: Al-Sharkia
Study officials:
affiliation: Lecturer of Anesthesia, Intensive Care & Pain management, Faculty of Medicine, Zagazig University
name: Ahmed Mohamed Fahmy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.