Comparing Local Anesthetic Techniques for Clavicular Surgeries

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220591
• Other study ID #: Clavicular anesthesia
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Zagazig University
• Contact: Mohamed Gaber, MD
• Phone: +201118851696
• Email: mgaber200098[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Zagazig university hospital	Zagazig	Al-Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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