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NCT Number: NCT07548775

Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery

This study aims to compare two local anesthesia techniques (nerve blocks) for patients undergoing collarbone (clavicle) fracture surgery.

Typically, this surgery uses the "Interscalene Block" (ISB) technique. However, this method carries risks of side effects such as shortness of breath because the nerves controlling the respiratory muscles may also be numbed. As an alternative, researchers want to test a newer combination: the "Clavipectoral Block" (CPB) combined with the "Superficial Cervical Block" (SCB).

The researchers want to determine if the new combination (SCB-CPB) provides pain relief as effective as the traditional technique (SCB-ISB), but with improved safety, particularly in maintaining the patient's respiratory stability and heart rate. During the study, patients will be randomly assigned to one of two groups:

SCB-CPB Group: Receives a combination of nerve blocks in the collarbone area.

SCB-ISB Group: Receives a combination of nerve blocks in the neck area (interscalene).

The results of this study are expected to provide a more comfortable and safer anesthesia option for patients undergoing clavicle surgery.

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Key information

Conditions

Clavicle Fracture Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Regional Anesthesia Block Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ngoerah Hospital

Denpasar, Bali, 80114, Indonesia

About this study

This study evaluates the clinical efficacy of a regional anesthesia technique that avoids the phrenic nerve involvement commonly seen in shoulder-related surgeries.

Study Rationale:

Clavicle fracture surgeries often require reliable anesthesia of the cervical plexus and branches of the brachial plexus. While the Interscalene Block (ISB) is a common choice, its association with phrenic nerve palsy and subsequent hemi-diaphragmatic paralysis poses risks for patients with respiratory compromise. The Clavipectoral Block (CPB) is a newer approach that targets the sensory nerves of the clavicle locally between the clavipectoral fascia and the periosteum, theoretically sparing the phrenic nerve.

Methods and Procedure:

Thirty-four (34) patients scheduled for elective clavicle surgery at RS Ngoerah will be enrolled and randomly assigned into two groups (n=17 per group):

SCB-CPB Group (Experimental): Participants receive a combination of Ultrasound-Guided (USG) Superficial Cervical Block and Clavipectoral Block using a total volume of 15-20 mL of local anesthetic (0.5% Bupivacaine or according to clinical protocol).

SCB-ISB Group (Control): Participants receive a combination of USG Superficial Cervical Block and Interscalene Block with the same volume and concentration of local anesthetic.

Clinical Assessment:

Block Performance: The time taken to perform the blocks (from probe placement to needle withdrawal) and the onset of sensory blockade will be recorded.

Intraoperative Management: Hemodynamic parameters (Heart Rate and Mean Arterial Pressure) will be monitored at T0 (baseline), T1 (post-block), T2 (incision), T3 (30 mins), T4 (60 mins), and T5 (post-op).

Success Rate: The incidence of "partial block" (requiring additional intraoperative rescue analgesia/sedation) will be compared between the two groups.

Post-operative Monitoring: The total duration of analgesia (time to first request for rescue analgesia) will be monitored for up to 24 hours post-operatively.

Statistical Analysis:

Data will be analyzed using normality tests (Shapiro-Wilk), followed by Independent T-tests or Mann-Whitney U tests for numerical data, and Chi-Square or Fisher's Exact tests for categorical data. Repeated measures ANOVA will be used for hemodynamic stability analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical Requirement: Patients scheduled to undergo elective or emergency surgery for clavicle fracture fixation (Open Reduction Internal Fixation).
  • Physical Status: Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II (healthy patients or those with mild systemic disease).
  • Age Range: Adult patients aged between 20 and 60 years.
  • Body Mass Index (BMI): Patients with a BMI within the range of 18.5 to 30kg/m2.
  • Cognitive Status: Patients who are conscious, cooperative, and able to communicate effectively to provide informed consent and report pain scores (VAS).
  • Consent: Patients who have voluntarily signed the written informed consent form after a full explanation of the procedure.

Exclusion criteria

  • Hypersensitivity or known allergy to local anesthetics. Patients presenting with respiratory compromise or significant pulmonary dysfunction.
  • Clinical history of coagulopathy or blood coagulation disorders.
  • Active infection at the site of needle insertion/puncture.
  • Chronic opioid consumption, defined as continuous use for three consecutive months.
  • Refusal to provide informed consent or participate in the study.

Treatment and study plan

Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB)

Procedure

The experimental intervention involves a specialized regional technique aimed at providing targeted anesthesia while minimizing motor weakness in the arm. The procedure begins with the patient in a supine position and the head turned to the opposite side. Under ultrasound guidance using a high-frequency linear probe, the physician identifies the clavipectoral fascia and the periosteum of the clavicle. After local skin infiltration with lidocaine, a block needle is inserted using an in-plane approach into the space between the pectoralis major muscle and the clavicular periosteum. A volume of 20 mL of an anesthetic mixture consisting of 0.25% Bupivacaine and 1% Lidocaine is injected both superiorly and inferiorly to the clavicle to surround the bone with anesthesia. Following this, the Superficial Cervical Block is performed by injecting an additional 10 mL of the same mixture at the posterior border of the sternocleidomastoid muscle. This approach is specifically chosen to provide sens

Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)

Procedure

The control intervention utilizes the standard interscalene approach, which is a well-established technique for shoulder and upper extremity surgery. With the patient positioned similarly and under ultrasound guidance, the practitioner identifies the interscalene groove located between the anterior and middle scalene muscles. The nerve roots of the brachial plexus, typically C5 and C6, are visualized as a "cluster of grapes" appearance. After skin infiltration, the needle is advanced until the tip is adjacent to these nerve roots, and 20 mL of the anesthetic mixture (0.25% Bupivacaine and 1% Lidocaine) is administered. To complete the sensory coverage required for the skin incision over the clavicle, a Superficial Cervical Block is also performed using 10 mL of the mixture at the lateral aspect of the sternocleidomastoid muscle. While this technique provides dense and reliable anesthesia for the surgical site, it inherently carries a higher risk of motor blockade in the upper limb and

Primary outcomes

  1. Duration of Analgesia

    Time frame: Up to 24 hours postoperatively.

    the primary objective is to evaluate and compare the total duration of effective analgesia provided by the two regional anesthesia techniques. This is defined as the time interval from the successful completion of the nerve block (confirmed by loss of sensation in the surgical area) until the patient first requests rescue analgesia or reports a pain intensity score of >3 on the Visual Analog Scale (VAS). A longer duration indicates a more effective and stable block for postoperative pain management

Secondary outcomes

  1. Time Taken to Perform Nerve Blocks

    Time frame: During the preoperative phase (at the time of the procedure).

    This measure evaluates the technical efficiency of the two regional anesthesia techniques. It is defined as the time interval (in minutes) from the moment the ultrasound probe first touches the patient's skin until the needle is withdrawn following the successful injection of the final volume of local anesthetic. This comparison helps determine if the Clavipectoral Block is more or less time-consuming to execute than the standard Interscalene Block

  2. Time to Onset of Sensory Block

    Time frame: Within 30 minutes after the nerve block procedure.

    The time (in minutes) from the completion of the local anesthetic injection until the patient achieves a complete loss of sensation (anesthesia) in the surgical area, as tested by the "pinprick" method.

  3. Mean Arterial Pressure (MAP)

    Time frame: From the time of nerve block administration (T1) through the end of the surgery and into the immediate postoperative recovery period (up to approximately 3 hours)

    This outcome measure evaluates perioperative hemodynamic stability by monitoring MAP during clavicle surgery. MAP is a critical indicator of organ perfusion and is sensitive to systemic stress responses from surgical stimuli. Data will be recorded at six clinical time points: T0 (baseline), T1 (post-nerve block), T2 (initial skin incision), T3 (opening of the clavicular periosteum), T4 (30 minutes intraoperatively), and T5 (60 minutes intraoperatively). The inclusion of T3 is vital as periosteal manipulation represents the most intense nociceptive stimulus in orthopedic surgery, requiring profound sensory blockade. The data will be compared between the SCB-CPB group and the SCB-ISB group. The objective is to determine which technique provides superior stability, characterized by minimal deviation from baseline and effective attenuation of hypertensive surges during high-intensity maneuvers. Ensuring MAP stability is paramount for mitigating complications and optimizing patient safety.

  4. Heart Rate (HR)

    Time frame: From the time of nerve block administration (T1) through the end of the surgery and into the immediate postoperative recovery period (up to approximately 3 hours)

    This outcome measure assesses cardiovascular stability by monitoring HR as a dynamic indicator during clavicle surgery. HR serves as a physiological proxy for sympathetic activation triggered by acute nociception or surgical stress, particularly during bone manipulation. HR data will be systematically recorded via continuous ECG monitoring at six standardized intervals: T0 (baseline), T1 (post-nerve block), T2 (initial skin incision), T3 (opening of the clavicular periosteum), T4 (30 minutes intraoperatively), and T5 (60 minutes intraoperatively). Measuring HR at T3 is crucial because the periosteum is densely innervated; its manipulation often triggers significant tachycardia if the regional block is inadequate. Heart rate profiles of the SCB-CPB group will be compared against the SCB-ISB group to identify the technique that maintains a more stable chronotropic profile. A stable HR indicates higher quality sensory blockade and efficient blunting of the autonomic stress response.

  5. Incidence of Partial or Incomplete Sensory Blockade

    Time frame: From 30 minutes post-block administration until the completion of the surgical procedure.

    This measure assesses the reliability and success rate of the anesthetic technique. A 'Partial Block' is defined as a condition where the patient still perceives sharp sensation (using the pinprick test) in any portion of the surgical field 30 minutes after the block is performed, or requires the conversion to general anesthesia or supplemental infiltration by the surgeon due to intraoperative pain. This outcome evaluates the anatomical coverage provided by the Clavipectoral vs. Interscalene approach

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

The Effectiveness of the Combination of Superficial Cervical Block With Clavipectoral Block Compared to the Combination With Interscalene Block in Clavicle Fracture Surgery

Acronym: BSS-BKvsBSS-BI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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