Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 25.02.2474-GHM | Registry Identifier | CEIm HM Hospitales |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult patients with midshaft clavicle fractures undergoing surgery under regional anesthesia at a tertiary-level hospital.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital HM Nou Delfos | Barcelona | Barcelona | 08023 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39444274 | Background | 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. | |
| 38470823 | 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. |
Not provided
Not provided
The individual participant data (IPD) will not be shared due to institutional policies and ethical considerations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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
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 | 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
| 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
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. | 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 | 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 | 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. | 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. | 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. |
| 38678917 | 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. |
| 37699731 | 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. |
| 36108196 | 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. |
| 35433386 | 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. |
| 36625982 | 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. |
| 35061634 | 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. |
| 36344406 | 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. |
| 31377668 | 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. |