Postoperative Pain ManagementMCBNCT06905249
Midclavicle Block: A Clinical Observational Study
An observational study of Postoperative Pain Management and Regional Anaesthesia, run by Hospital HM Nou Delfos at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Management, Regional Anaesthesia, Ultrasound Guided
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with midshaft clavicle fractures undergoing surgery under regional anesthesia at a tertiary-level hospital.
Who may be able to join
- Adult patients with midshaft clavicle fractures scheduled for surgery.
- ASA I-III.
- Signed informed consent.
Who cannot join
- Allergy to local anesthetics.
- Coagulopathy or active anticoagulant therapy.
- Infection at the puncture site.
- Pregnant or breastfeeding patients.
- Pre-existing neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Clavicle Fracture, ultrasound guided, Midclavicle Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period
Secondary outcomes (11)
Postoperative Pain Assessment Using Visual Analog Scale
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.
Measured: Immediate postoperative period, and at 6, 12, and 24 hours postoperatively
Sedation Level Assessed by the Ramsay Sedation Scale
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.
Measured: 30 minutes and 2 hours post-block
Incidence of Hemidiaphragmatic Paralysis Assessed by M-mode Ultrasound
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.
Measured: Baseline (pre-block), 30 minutes and 2 hours after the block
Assessment of Motor Block in the Ipsilateral Upper Limb
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
- = paresis
- = paralysis
The total motor block score will range from 0 to 10.
Measured: Pre-block (baseline), 30 minutes and 2 hours post-block
Assessment of Sensory Block in the Ipsilateral Upper Limb
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
- = decreased sensation to pinprick
- = no sensation to pinprick Sensory block will be considered effective if a score of 1 or 2 is present in at least two dermatomes.
Measured: 30 minutes and 2 hours post-block
Assessment of Sensory Block in the Clavicle Region
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
- = decreased sensitivity to pinprick
- = no sensitivity to pinprick
- = no tactile sensation
Sensory block will be considered effective if the score is 2 or 3 in the assessed area.
Measured: 30 minutes and 2 hours post-block
Requirement for Postoperative Rescue Analgesia.
Assess the need for rescue analgesia within the first 24 postoperative hours, including the type of analgesic administered and the doses required.
Measured: 24 hours postoperative.
Continuous Monitoring of Nociception and Sedation Using Qnox and Qcon
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.
Measured: Intraoperative period
Incidence of Intraoperative and Postoperative Systemic Complications Related to the Midclavicle Block
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.
Measured: During surgery and up to 24 hours postoperatively.
Onset Time and Duration of the Midclavicular Block Procedure.
Measure the onset time of the midclavicular block after local anesthetic injection, as well as the total time required to perform the technique.
Measured: Intraoperative
Evaluation of Hemodynamic Stability.
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.
Measured: Intraoperative period and up to 2 hours post-block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start2 Dec 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital HM Nou Delfos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HIPÓLITO LABANDEYRA GONZALEZ, Hospital HM Nou Delfos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905249
- Sponsor's protocol ID
- 25.02.2474-GHM
- Other IDs
- 25.02.2474-GHM
- Acronym
- MCB
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to institutional policies and ethical considerations.
Publications
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.
PubMed 39444274Heredia-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.
PubMed 38470823Labandeyra 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.
PubMed 38678917Labandeyra 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.
PubMed 37699731Labandeyra 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.
PubMed 36108196Abu 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.
PubMed 35433386Xu 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.
PubMed 36625982Zhuo 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.
PubMed 35061634Labandeyra 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.
PubMed 36344406Ince 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.
PubMed 31377668
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midclavicle Block: A Clinical Observational Study
- ClinicalTrials.gov ID
- NCT06905249
- Acronym / sponsor ID
- MCB / 25.02.2474-GHM
- Keywords
- Clavicle Fracture, ultrasound guided, Midclavicle Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital HM Nou DelfosUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with midshaft clavicle fractures undergoing surgery under regional anesthesia at a tertiary-level hospital.
Key inclusion criteria (3 listed)
- Adult patients with midshaft clavicle fractures scheduled for surgery.
- ASA I-III.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Allergy to local anesthetics.
- Coagulopathy or active anticoagulant therapy.
- Infection at the puncture site.
- Pregnant or breastfeeding patients.
- Pre-existing neuromuscular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Postoperative Pain Assessment Using Visual Analog Scale
Time frame: 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
Incidence of Hemidiaphragmatic Paralysis Assessed by M-mode Ultrasound
Time frame: 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
Assessment of Sensory Block in the Ipsilateral Upper Limb
Time frame: 30 minutes and 2 hours post-block
Assessment of Sensory Block in the Clavicle Region
Time frame: 30 minutes and 2 hours post-block
Requirement for Postoperative Rescue Analgesia.
Time frame: 24 hours postoperative.
Continuous Monitoring of Nociception and Sedation Using Qnox and Qcon
Time frame: Intraoperative period
Incidence of Intraoperative and Postoperative Systemic Complications Related to the Midclavicle Block
Time frame: During surgery and up to 24 hours postoperatively.
Onset Time and Duration of the Midclavicular Block Procedure.
Time frame: Intraoperative
Evaluation of Hemodynamic Stability.
Time frame: Intraoperative period and up to 2 hours post-block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 39444274Labandeyra 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.
- Background: PubMed 38470823Heredia-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.
- Background: PubMed 38678917Labandeyra 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.
- Background: PubMed 37699731Labandeyra 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.
- Background: PubMed 36108196Labandeyra 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.
- Background: PubMed 35433386Abu 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.
- Background: PubMed 36625982Xu 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.
- Background: PubMed 35061634Zhuo 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.
- Background: PubMed 36344406Labandeyra 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.
- Background: PubMed 31377668Ince 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.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to institutional policies and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Management and Regional Anaesthesia, run by Hospital HM Nou Delfos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Pain Assessment Using the Visual Analog Scale (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905249, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.