Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery (BSS-BKvsBSS-BI)

Udayana University

Status: Active, not recruiting

Conditions: Postoperative Pain; Regional Anesthesia Block; Clavicle Fracture

Treatments: Procedure: Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB); Procedure: Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07548775

1663/UN14.2.2.VII.14/LT/2026 (Other Identifier)

YAS-CLAVI-BPSS-2026

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

SCB + CPB Group

Experimental group

Description:

This group consists of participants undergoing surgical fixation for clavicle fractures who are assigned to receive a regional anesthesia combination targeting the local anatomy of the collarbone. This arm specifically evaluates the efficacy of blocking the sensory nerves without involving the deeper brachial plexus structures

Treatment:

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

SCB + ISB Group

Active Comparator group

Description:

This group serves as the active control, representing the conventional regional anesthesia approach for clavicle and shoulder procedures. Participants in this arm receive the standard nerve block combination to provide a baseline for comparing pain relief and safety profiles

Treatment:

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