Midclavicle Block: A Clinical Observational Study

NCT06905249 | Completed

• 1 other identifier: 25.02.2474-GHM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the effectiveness and safety of the ultrasound-guided Midclavicle Block (MCB) as an anesthetic and analgesic technique for midshaft clavicle fracture surgery. The primary objective is to assess intraoperative pain control using the Visual Analog Scale (VAS). Secondary outcomes include postoperative pain, sedation levels (Ramsay scale), motor and sensory block of the ipsilateral upper limb, hemidiaphragmatic paralysis, and hemodynamic stability. The requirement for rescue analgesia and the incidence of systemic complications will also be recorded. Intraoperative Qnox and Qcon monitoring will be used to explore potential correlations with pain and sedation levels. Data will be collected intraoperatively and postoperatively for up to 24 hours.

Conditions

Postoperative Pain Management; Regional Anaesthesia; Ultrasound Guided; Clavicle Fracture

Keywords

Clavicle Fracture; ultrasound guided; Midclavicle Block

Outcome Measures

Primary Outcomes (1)

• Intraoperative Pain Assessment Using the Visual Analog Scale

  Intraoperative pain will be assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 represents the worst imaginable pain. Pain scores will be recorded during the procedure whenever feasible, in awake patients, to evaluate the anesthetic effectiveness of the midclavicle block.

  Intraoperative period

Secondary Outcomes (11)

• Postoperative Pain Assessment Using Visual Analog Scale

  Immediate postoperative period, and at 6, 12, and 24 hours postoperatively

• Sedation Level Assessed by the Ramsay Sedation Scale

  30 minutes and 2 hours post-block

• Incidence of Hemidiaphragmatic Paralysis Assessed by M-mode Ultrasound

  Baseline (pre-block), 30 minutes and 2 hours after the block

• Assessment of Motor Block in the Ipsilateral Upper Limb

  Pre-block (baseline), 30 minutes and 2 hours post-block

• Assessment of Sensory Block in the Ipsilateral Upper Limb

  30 minutes and 2 hours post-block

Study Arms (1)

Midshaft Clavicle Fracture Surgery Cohort

Patients undergoing ultrasound-guided midclavicle block for midshaft clavicle fracture surgery. The study evaluates intraoperative and postoperative pain (VAS), sedation levels (Ramsay), diaphragmatic movement (ultrasound), motor and sensory block of the ipsilateral upper limb, sensory block in the clavicle region, hemodynamic stability (BP, HR, SpO₂), onset time and duration of the block, requirement for rescue analgesia, and the incidence of block-related or systemic complications. Qnox and Qcon indices will be continuously recorded intraoperatively for exploratory purposes. Data collection will cover intraoperative and up to 24-hour postoperative periods.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with midshaft clavicle fractures undergoing surgery under regional anesthesia at a tertiary-level hospital.

You may qualify if:

• Adult patients with midshaft clavicle fractures scheduled for surgery.
• ASA I-III.
• Signed informed consent.

You may not qualify if:

• Allergy to local anesthetics.
• Coagulopathy or active anticoagulant therapy.
• Infection at the puncture site.
• Pregnant or breastfeeding patients.
• Pre-existing neuromuscular disorders.

Sponsors & Collaborators

• Hospital HM Nou Delfos: lead

Study Sites (1)

Hospital HM Nou Delfos

Barcelona, Barcelona, 08023, Spain

Location

Related Publications (10)

• Labandeyra H, Valdes-Vilches LF, Prats-Galino A, Sala-Blanch X. Midclavicle block: An anatomical study. Eur J Anaesthesiol. 2025 Feb 1;42(2):122-130. doi: 10.1097/EJA.0000000000002079. Epub 2024 Oct 23.

  PMID: 39444274 BACKGROUND

• Heredia-Carques C, Labandeyra H, Castellanos M, Valdes-Vilches LF, Tomas X, Sala-Blanch X. Clavipectoral Fascia and Clavipectoral Fascia Plane Block: To Be or Not to Be. Anesth Analg. 2024 Aug 1;139(2):446-448. doi: 10.1213/ANE.0000000000006837. Epub 2024 Mar 12. No abstract available.

  PMID: 38470823 BACKGROUND

• Labandeyra H, Heredia C, Valdes-Vilches LF, Prats-Galino A, Sala-Blanch X. Clavipectoral fascia plane block in midshaft clavicle fractures: A cadaveric study. J Clin Anesth. 2024 Sep;96:111469. doi: 10.1016/j.jclinane.2024.111469. Epub 2024 Apr 27.

  PMID: 38678917 BACKGROUND

• Labandeyra H, Heredia-Carques C, Campoy JC, Valdes-Vilches LF, Prats-Galino A, Sala-Blanch X. Clavipectoral fascia plane block spread: an anatomical study. Reg Anesth Pain Med. 2024 May 7;49(5):368-372. doi: 10.1136/rapm-2023-104785.

  PMID: 37699731 BACKGROUND

• Labandeyra H, Heredia C, Valdes-Vilches LF, Sala-Blanch X. Clavipectoral Fascia Plane Block: Is This Hyperreality? Anesth Analg. 2022 Oct 1;135(4):e23-e24. doi: 10.1213/ANE.0000000000006150. Epub 2022 Sep 15. No abstract available.

  PMID: 36108196 BACKGROUND

• Abu Sabaa MA, Elbadry AA, El Malla DA. Ultrasound-Guided Clavipectoral Block for Postoperative Analgesia of Clavicular Surgery: A Prospective Randomized Trial. Anesth Pain Med. 2022 Mar 8;12(1):e121267. doi: 10.5812/aapm.121267. eCollection 2022 Feb.

  PMID: 35433386 BACKGROUND

• Xu G, Su P, Cai B, Liu Y, Jiang D, He Y, Zhou M, Zhang M. Ultrasound-guided superficial cervical plexus block combined with clavipectoral fascial plane block or interscalene brachial plexus block in clavicle surgery: a single-centre, double-blind, randomized controlled trial. J Clin Monit Comput. 2023 Aug;37(4):985-992. doi: 10.1007/s10877-022-00968-1. Epub 2023 Jan 10.

  PMID: 36625982 BACKGROUND

• Zhuo Q, Zheng Y, Hu Z, Xiong J, Wu Y, Zheng Y, Wang L. Ultrasound-Guided Clavipectoral Fascial Plane Block With Intermediate Cervical Plexus Block for Midshaft Clavicular Surgery: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Sep 1;135(3):633-640. doi: 10.1213/ANE.0000000000005911. Epub 2022 Jan 21.

  PMID: 35061634 BACKGROUND

• Labandeyra H, Furno JL, Campos JL, Roques Escolar V, Valdes Vilches LF. Ultrasound-guided clavipectoral fascia plane block for middle third clavicular fracture: A case series. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Dec;69(10):683-688. doi: 10.1016/j.redare.2021.12.002. Epub 2022 Nov 4.

  PMID: 36344406 BACKGROUND

• Ince I, Kilicaslan A, Roques V, Elsharkawy H, Valdes L. Ultrasound-guided clavipectoral fascial plane block in a patient undergoing clavicular surgery. J Clin Anesth. 2019 Dec;58:125-127. doi: 10.1016/j.jclinane.2019.07.011. Epub 2019 Aug 1. No abstract available.

  PMID: 31377668 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: December 2, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)