Comparing Local Anesthetic Techniques for Clavicular Surgeries

NCT ID: NCT06220591

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-27

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Superior trunk block

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Clavipectoral fascial plane block

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Mohamed Fahmy, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Zagazig university hospital

Zagazig, Al-Sharkia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 12378163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22248169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31031496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24747317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31490292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37692707 (View on PubMed)

Other Identifiers

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Clavicular anesthesia

Identifier Type: -

Identifier Source: org_study_id

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