Comparing Local Anesthetic Techniques for Clavicular Surgeries

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: Recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: Superior trunk block; Procedure: Clavipectoral fascial plane block

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: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Gaber, MD; Phone Number: +201118851696; Email: mgaber200098@gmail.com
• Study Contact Backup: Name: ALshaimaa Abdel Fattah Kamel, MD; Phone Number: +201005593169; Email: AlshaimaaKamel80@yahoo.com

Study Locations

• Egypt
  • Al-Sharkia
    • Zagazig, Al-Sharkia, Egypt, 44519
      • Recruiting
      • Zagazig University Hospital
      • Contact: Mohamed Gaber, MD; Email: mgaber200098@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 minutes
Ipsilateral diaphragmatic excursion affection.	Ipsilateral diaphragmatic excursion will be assessed by M-mode ultrasound.	1 hour
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.	24 hours.
The total opioid consumption in the first 24 hours	The total dose of intravenous nalbuphine in the first 24 hours postoperatively	24 hours.
Patient and surgeon satisfaction.	Patient and surgeon satisfaction will be assessed using 7- point Likert-like verbal rating scale.	24 hours
Any reported complications.	The possible side effects will be followed in the first 24 hours postoperative.	24 hours.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Ahmed Mohamed Fahmy, MD, Lecturer of Anesthesia, Intensive Care & Pain management, Faculty of Medicine, Zagazig University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Estimated): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Clavicular anesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No