Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery

NCT07548775 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

PROCEDURE

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

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

Sponsors & Collaborators

  • Udayana University

    lead OTHER

Principal Investigators

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

  • Pontisomaya Parami, MD, PhD, Sp.An,FCC · Udayana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2026-07-16
Completion
2026-07-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07548775 on ClinicalTrials.gov