Clavicle FractureBSS-BKvsBSS-BINCT07548775
Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery
A study testing Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB) and Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB) in people with Clavicle Fracture and Postoperative Pain, run by Udayana University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Clavicle Fracture, Postoperative Pain, Regional Anesthesia Block
- What is being tested?
- Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB) and Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Apr 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Combination of Superficial Cervical Block With Clavipectoral Block Compared to the Combination With Interscalene Block in Clavicle Fracture Surgery
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).
Read more
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.
Read the detailed 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.
- Being tested
- Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB), Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)
- 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
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB)Procedure or surgery
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
Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 hours postoperatively.
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From 30 minutes post-block administration until the completion of the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start16 Apr 2026
- Primary completion16 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Andi Setiyawan, Udayana University
- Investigators
- I Gusti Ngurah M Arimbawa, MD, PhD, Sp.An, Subsp.An.R,FIP, Study chair, Udayana UniversityPontisomaya Parami, MD, PhD, Sp.An,FCC, Study chair, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548775
- Sponsor's protocol ID
- YAS-CLAVI-BPSS-2026
- Other IDs
- 1663/UN14.2.2.VII.14/LT/2026
- Acronym
- BSS-BKvsBSS-BI
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Combination of Superficial Cervical Block With Clavipectoral Block Compared to the Combination With Interscalene Block in Clavicle Fracture Surgery
- ClinicalTrials.gov ID
- NCT07548775
- Acronym / sponsor ID
- BSS-BKvsBSS-BI / YAS-CLAVI-BPSS-2026
- Keywords
- Clavipectoral Block, Superficial Cervical Block, Interscalene Block, Clavicle Fracture Surgery, Regional Anesthesia, Peripheral Nerve Block, Ultrasound-Guided Anesthesia, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SCB + CPB Group | Experimental | Procedure: Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB)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 | Procedure: Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB)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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | SCB + CPB Group |
| 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 | Procedure or surgery | SCB + ISB Group |
Primary outcome
Duration of Analgesia
Time frame: Up to 24 hours postoperatively.
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
5 secondary outcomes
Time Taken to Perform Nerve Blocks
Time frame: During the preoperative phase (at the time of the procedure).
Time to Onset of Sensory Block
Time frame: Within 30 minutes after the nerve block procedure.
Mean Arterial Pressure (MAP)
Time frame: 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)
Time frame: 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
Time frame: From 30 minutes post-block administration until the completion of the surgical procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- udayana university official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I Gusti Ngurah M Arimbawa, MD, PhD, Sp.An, Subsp.An.R,FIP study chair
Udayana University
Pontisomaya Parami, MD, PhD, Sp.An,FCC study chair
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB) and Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB) in people with Clavicle Fracture and Postoperative Pain, run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Analgesia (time frame: Up to 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.