Midclavicle Block: A Clinical Observational Study (MCB)

July 1, 2025 updated by: HIPÓLITO LABANDEYRA GONZALEZ, Hospital HM Nou Delfos
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08023
        • Hospital HM Nou Delfos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Pain Assessment Using the Visual Analog Scale
Time Frame: Intraoperative period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Assessment Using Visual Analog Scale
Time Frame: Immediate postoperative period, and at 6, 12, and 24 hours postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded in the immediate postoperative period, as well as at 6, 12, and 24 hours after surgery to evaluate the analgesic efficacy of the midclavicle block throughout the early recovery phase.
Immediate postoperative period, and at 6, 12, and 24 hours postoperatively
Sedation Level Assessed by the Ramsay Sedation Scale
Time Frame: 30 minutes and 2 hours post-block
Sedation will be assessed at 30 minutes and 2 hours after block performance using the Ramsay Sedation Scale, a widely used clinical tool ranging from 1 (anxious or agitated) to 6 (no response to stimuli). This outcome aims to determine whether patients remain adequately awake and cooperative under regional anesthesia.
30 minutes and 2 hours post-block
Incidence of Hemidiaphragmatic Paralysis Assessed by M-mode Ultrasound
Time Frame: Baseline (pre-block), 30 minutes and 2 hours after the block
Hemidiaphragmatic function will be evaluated using M-mode ultrasonography before the block and at 30 minutes and 2 hours post-block. The measurement will be performed at the right anterior axillary line in the subcostal area, using the liver as an acoustic window. Diaphragmatic excursion will be measured during deep breathing. Hemidiaphragmatic paralysis is defined as a reduction of more than 50% in diaphragmatic excursion compared to baseline, and/or paradoxical movement during sniff testing.
Baseline (pre-block), 30 minutes and 2 hours after the block
Assessment of Motor Block in the Ipsilateral Upper Limb
Time Frame: Pre-block (baseline), 30 minutes and 2 hours post-block

Motor block will be assessed before the block, and at 30 minutes and 2 hours after block performance. The evaluation will include motor function in the distribution of the axillary (shoulder abduction), musculocutaneous (elbow flexion), radial (wrist extension), median (wrist flexion), and ulnar (thumb/finger adduction) nerves. Each nerve will be scored using a 3-point scale:

0 = normal strength

  1. = paresis
  2. = paralysis

The total motor block score will range from 0 to 10.
Pre-block (baseline), 30 minutes and 2 hours post-block
Assessment of Sensory Block in the Ipsilateral Upper Limb
Time Frame: 30 minutes and 2 hours post-block

Sensory function will be assessed by testing response to pinprick in four dermatomes of the ipsilateral upper limb: C5 (deltoid area), C6 (lateral forearm), C7 (dorsum of the hand), and C8 (medial forearm). A 3-point scale will be used in each area:

0 = normal sensation

  1. = decreased sensation to pinprick
  2. = no sensation to pinprick Sensory block will be considered effective if a score of 1 or 2 is present in at least two dermatomes.
30 minutes and 2 hours post-block
Assessment of Sensory Block in the Clavicle Region
Time Frame: 30 minutes and 2 hours post-block

Sensory block will be assessed at 30 minutes and 2 hours after block performance in three anatomical areas: the sternoclavicular joint, midclavicle, and acromioclavicular joint. A 4-point scale will be used:

0 = no reduction in sensation

  1. = decreased sensitivity to pinprick
  2. = no sensitivity to pinprick
  3. = no tactile sensation

Sensory block will be considered effective if the score is 2 or 3 in the assessed area.
30 minutes and 2 hours post-block
Requirement for Postoperative Rescue Analgesia.
Time Frame: 24 hours postoperative.
Assess the need for rescue analgesia within the first 24 postoperative hours, including the type of analgesic administered and the doses required.
24 hours postoperative.
Continuous Monitoring of Nociception and Sedation Using Qnox and Qcon
Time Frame: Intraoperative period
During the surgical procedure, continuous monitoring of the Qnox and Qcon indices will be performed using a neurological state monitor with frontal sensors. The Qnox index provides an objective estimate of the patient's nociceptive response, while the Qcon index estimates the level of consciousness.
Intraoperative period
Incidence of Intraoperative and Postoperative Systemic Complications Related to the Midclavicle Block
Time Frame: During surgery and up to 24 hours postoperatively.
The incidence of intraoperative and postoperative systemic complications potentially related to the Midclavicle Block (MCB) will be recorded. These include hypotension, bradycardia, nausea, and vomiting.
During surgery and up to 24 hours postoperatively.
Onset Time and Duration of the Midclavicular Block Procedure.
Time Frame: Intraoperative
Measure the onset time of the midclavicular block after local anesthetic injection, as well as the total time required to perform the technique.
Intraoperative
Evaluation of Hemodynamic Stability.
Time Frame: Intraoperative period and up to 2 hours post-block.
Hemodynamic stability will be assessed intraoperatively and during the immediate postoperative period by monitoring non-invasive blood pressure (NIBP), heart rate (HR), and peripheral oxygen saturation (SpO₂). Any episode of hypotension (defined as a systolic blood pressure <90 mmHg or a decrease of >20% from baseline) or bradycardia (heart rate <50 bpm) will be recorded and treated as per standard protocol.
Intraoperative period and up to 2 hours post-block.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital HM Nou Delfos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.02.2474-GHM (Registry Identifier: CEIm HM Hospitales)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) will not be shared due to institutional policies and ethical considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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