Effect of Intravenous Dexamethasone Added to Intravenous Dexmedetomidine on Postoperative Analgesia After Superior Trunk Block for Arthroscopic Shoulder Surgery: A Prospective, Randomized, Placebo-Controlled, Triple-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Time to first rescue analgesic request
研究概览
简要总结
This study aims to evaluate whether adding intravenous dexamethasone to standard intravenous dexmedetomidine improves pain control after shoulder arthroscopy performed under a superior trunk block. Shoulder arthroscopy is a common surgical procedure that can cause moderate to severe postoperative pain.
In this study, adult patients undergoing elective arthroscopic shoulder surgery will receive a nerve block called a superior trunk block to control pain during and after surgery. All participants will also receive intravenous dexmedetomidine, a medication commonly used to enhance analgesia.
Participants will be randomly assigned to one of two groups. One group will receive intravenous dexamethasone, while the other group will receive a placebo (saline solution). Neither the patients nor the healthcare providers nor the outcome assessors will know which treatment each participant receives.
The main goal of the study is to determine how long it takes before patients require their first additional pain medication after surgery. Secondary outcomes include pain scores, total pain medication use, duration of nerve block, rebound pain, side effects, and patient satisfaction.
The findings of this study may help improve postoperative pain management strategies for patients undergoing shoulder arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective arthroscopic shoulder surgery
- •Body mass index (BMI) between 18.5 and 35 kg/m²
- •Ability to understand the study protocol and provide written informed consent
排除标准
- •Refusal to participate or inability to provide informed consent Contraindications to peripheral nerve block (e.g., coagulopathy, infection at the injection site) Known allergy or hypersensitivity to study medications (dexamethasone, dexmedetomidine, or local anesthetics) Pregnancy or breastfeeding Chronic opioid use or opioid dependence Pre-existing neurological deficit involving the operative upper extremity Severe hepatic or renal dysfunction Uncontrolled diabetes mellitus Body mass index (BMI) >35 kg/m² Infection at the planned block site Participation in another interventional clinical trial within the last 30 days
研究组 & 干预措施
Placebo Group
干预措施: Sodium Chloride 0.9% (Drug)
Intravenous Dexamethasone Group
干预措施: Dexmedetomidine (Drug)
Placebo Group
干预措施: Dexmedetomidine (Drug)
Intravenous Dexamethasone Group
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Time to first rescue analgesic request
时间窗: From completion of superior trunk block to first rescue analgesic request, up to 72 hours postoperatively
Time from completion of the superior trunk block to the first administration of rescue analgesia, defined as analgesic requirement for Numeric Rating Scale (NRS) \>3 or upon patient request.
次要结局
- Rebound pain incidence(Through 72 hours postoperatively)
研究者
Recep Karakaşoğlu
Specialist in Anesthesiology and Reanimation
Gaziantep City Hospital