The Effectiveness of the Combination of Superficial Cervical Block With Clavipectoral Block Compared to the Combination With Interscalene Block in Clavicle Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
SCB + CPB Group
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
干预措施: Combination of Superficial Cervical Block and Clavipectoral Block (SCB + CPB) (Procedure)
SCB + ISB Group
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
干预措施: Combination of Superficial Cervical Block and Interscalene Block (SCB + ISB) (Procedure)
结局指标
主要结局
Duration of Analgesia
时间窗: 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
次要结局
- 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.)
研究者
Yusuf Andi Setiyawan
resident doctor in an Anesthesiology and Intensive Therapy Specialist Program
Udayana University