Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1663/UN14.2.2.VII.14/LT/2026 | Other Identifier | Fakultas Kedokteran, Universitas Udayana |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken to Perform Nerve Blocks | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ngoerah Hospital | Denpasar | Bali | 80114 | Indonesia |
Not provided
| Label | URL |
|---|---|
| udayana university official website | View source |
Not provided
Individual participant data will not be shared to ensure the privacy and confidentiality of the study participants in accordance with institutional ethics committee policies. However, the study protocol and the final analyzed results (aggregated data) will be available through the final research report or publication.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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
|
| 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 |
|
| During the preoperative phase (at the time of the procedure). |
| Time to Onset of Sensory Block | 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. | Within 30 minutes after the nerve block procedure. |
| Mean Arterial Pressure (MAP) | 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. | 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) | 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. | 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 | 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 | From 30 minutes post-block administration until the completion of the surgical procedure. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided