Clinical trial NCT06905249: Midclavicle Block: A Clinical Observational Study
Official title: Midclavicle Block: A Clinical Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain Management
Regional Anaesthesia
Ultrasound Guided
Clavicle Fracture
Keywords: Clavicle Fracture
ultrasound guided
Midclavicle Block
Lead sponsor: Hospital HM Nou Delfos
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with midshaft clavicle fractures undergoing surgery under regional anesthesia at a tertiary-level hospital.

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.

Detailed description: This prospective observational study aims to evaluate the effectiveness of the Midclavicle Block (MCB) as an anesthetic and analgesic technique in patients undergoing clavicle fracture surgery. The primary outcome is intraoperative pain control, assessed using the Visual Analog Scale (VAS) in awake patients, to determine the anesthetic effectiveness of the block.

The MCB will be performed under ultrasound guidance with a linear transducer placed in the sagittal plane immediately posterior to the midclavicle. Local anesthetic will be administered via three injections: two 15 mL injections on either side of the fracture site over the anterosuperior periosteum of the clavicle, and a third 10 mL injection crossing the subclavius muscle toward the posteroinferior region of the periosteum. The total volume of local anesthetic administered will be 40 mL.

Secondary outcomes include:

Postoperative pain, assessed using the VAS at immediate recovery and at 6, 12, and 24 hours postoperatively.

Sedation levels, measured with the Ramsay Sedation Scale at 30 minutes and 2 hours after block placement.

Incidence of hemidiaphragmatic paralysis, evaluated with M-mode ultrasound before and after the block, based on diaphragmatic excursion during deep breathing and sniff testing.

Motor block in the ipsilateral upper limb, scored in five nerve distributions (axillary, musculocutaneous, radial, median, ulnar) at baseline, 30 minutes, and 2 hours post-block.

Sensory block in the ipsilateral upper limb, assessed by pinprick in four dermatomes (C5-C8), scored at 30 minutes and 2 hours.

Sensory block in the clavicular region, evaluated over the sternoclavicular joint, midclavicle, and acromioclavicular joint at 30 minutes and 2 hours.

Requirement for postoperative rescue analgesia within the first 24 hours, including type and dosage.

Continuous intraoperative monitoring of Qnox and Qcon indices, to explore their correlation with nociceptive and sedation levels. Qnox estimates nociceptive response; Qcon estimates level of consciousness.

Incidence of systemic complications related to the block, such as hypotension, bradycardia, nausea, or vomiting.

Block onset time and duration, including the time to perform the MCB and onset of anesthetic effect.

Hemodynamic stability, assessed intraoperatively and up to 2 hours postoperatively, by monitoring non-invasive blood pressure, heart rate, and oxygen saturation. Episodes of hypotension (SBP \<90 mmHg or \>20% drop from baseline) or bradycardia (HR \<50 bpm) will be recorded.

The study will enroll 30 adult patients (ages 18-75) scheduled for clavicle fracture surgery at HM Nou Delfos Hospital. Data collection will span intraoperative and early postoperative periods, up to 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Intraoperative Pain Assessment Using the Visual Analog Scale
timeFrame: Intraoperative period
Secondary outcomes:
measure: Postoperative Pain Assessment Using Visual Analog Scale
timeFrame: Immediate postoperative period, and at 6, 12, and 24 hours postoperatively
measure: Sedation Level Assessed by the Ramsay Sedation Scale
timeFrame: 30 minutes and 2 hours post-block
measure: Incidence of Hemidiaphragmatic Paralysis Assessed by M-mode Ultrasound
timeFrame: Baseline (pre-block), 30 minutes and 2 hours after the block
measure: Assessment of Motor Block in the Ipsilateral Upper Limb
timeFrame: Pre-block (baseline), 30 minutes and 2 hours post-block
measure: Assessment of Sensory Block in the Ipsilateral Upper Limb
timeFrame: 30 minutes and 2 hours post-block
measure: Assessment of Sensory Block in the Clavicle Region
timeFrame: 30 minutes and 2 hours post-block
measure: Requirement for Postoperative Rescue Analgesia.
timeFrame: 24 hours postoperative.
measure: Continuous Monitoring of Nociception and Sedation Using Qnox and Qcon
timeFrame: Intraoperative period
measure: Incidence of Intraoperative and Postoperative Systemic Complications Related to the Midclavicle Block
timeFrame: During surgery and up to 24 hours postoperatively.
measure: Onset Time and Duration of the Midclavicular Block Procedure.
timeFrame: Intraoperative
measure: Evaluation of Hemodynamic Stability.
timeFrame: Intraoperative period and up to 2 hours post-block.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital HM Nou Delfos
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.