Език: EN EN
← Назад към резултатите
Активно (без набиране) Не е приложимо NCT07548775

Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery

Не е приложима фаза (напр. обсервационно)
Заболявания: Clavicle Fracture Postoperative Pain Regional Anesthesia Block

Спонсор: Udayana University

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Интервенции
Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB)
PROCEDURE
Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)
PROCEDURE
Места на провеждане 1
Indonesia (1)
Ngoerah Hospital
Denpasar , Bali
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
20 Years
Максимална възраст
60 Years
Здрави доброволци
Не
Начална дата
16.04.2026
Крайна дата
30.07.2026
Регистрационен номер
NCT07548775
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.