Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery

NCT07548775 | Active Not Recruiting

• 2 other identifiers: YAS-CLAVI-BPSS-20261663/UN14.2.2.VII.14/LT/2026
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clavicle Fracture; Postoperative Pain; Regional Anesthesia Block

Keywords

Clavipectoral Block; Superficial Cervical Block; Interscalene Block; Clavicle Fracture Surgery; Regional Anesthesia; Peripheral Nerve Block; Ultrasound-Guided Anesthesia; Postoperative Analgesia; Phrenic Nerve Sparing; Acute Pain Management

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  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

  Up to 24 hours postoperatively.

Secondary Outcomes (5)

• Time Taken to Perform Nerve Blocks

  During the preoperative phase (at the time of the procedure).

• Time to Onset of Sensory Block

  Within 30 minutes after the nerve block procedure.

• Mean Arterial Pressure (MAP)

  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)

• Heart Rate (HR)

  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)

• Incidence of Partial or Incomplete Sensory Blockade

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

Study Arms (2)

SCB + CPB Group

EXPERIMENTAL

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

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

SCB + ISB Group

ACTIVE COMPARATOR

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

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

Interventions

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

SCB + CPB Group

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

SCB + ISB Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Ngoerah Hospital

Denpasar, Bali, 80114, Indonesia

Location

Related Links

• udayana university official website

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• I Gusti Ngurah M Arimbawa, MD, PhD, Sp.An, Subsp.An.R,FIP

  Udayana University

  STUDY CHAIR

• Pontisomaya Parami, MD, PhD, Sp.An,FCC

  Udayana University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is conducted as a double-blind trial to ensure the objectivity of the clinical findings. While the anesthesiologist performing the nerve blocks is aware of the group assignment due to the nature of the procedural intervention, they are not involved in any subsequent data collection or outcome assessment. To maintain blinding for the participants, they are informed only that they will receive one of two regional anesthesia combinations without being told which specific technique is administered. Furthermore, the researchers acting as outcomes assessors, who evaluate critical parameters such as hemodynamic stability, pain scores, and the duration of analgesia-remain masked to the treatment allocation until the study is completed and the data is analyzed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor in an Anesthesiology and Intensive Therapy Specialist Program

Model Details: This is a randomized, double-blind, controlled clinical trial using a Parallel Assignment model to compare two regional anesthesia techniques for clavicle fracture surgery. Thirty-four (34) eligible participants are assigned to one of two treatment arms in a 1:1 ratio. The Experimental Group (SCB-CPB) receives a combination of Ultrasound-Guided (USG) Superficial Cervical Block and Clavipectoral Block. The Control Group (SCB-ISB) receives a combination of USG Superficial Cervical Block and Interscalene Block. To ensure objectivity, the study utilizes a double-blind approach where both the patients and the outcome evaluators are masked to the group assignments. All procedures are performed under USG guidance to optimize safety. Clinical outcomes, including hemodynamic stability, block onset, and total duration of analgesia, are monitored continuously through 24 hours post-operatively.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 23, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)