Ultrasound-guided Shoulder PENG Block Versus Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Arthroscopy; A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
研究概览
简要总结
Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome.
In this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.
详细描述
As a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval.
64 patients who meet the inclusion criteria will be included in our study. The participants will be randomized and divided into 2 groups. Accordingly, the PENG block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will have shoulder arthroscopy surgery under general anesthesia
- •Ages of 18-75
- •ASA I-III
排除标准
- •Patients with deformity and pathology in the shoulder region
- •Patients with known local anesthetic allergy
- •Patients with BMI>35
- •Patients with alcohol and substance addiction
- •Patients with opioid addiction
- •Patients who cannot perceive and evaluate pain, such as psychiatric illness, mental retardation
研究组 & 干预措施
Group PENG
The investigators performed a pericapsular nerve block on that patient group for postoperative analgesia.
干预措施: Pericapsular nerve block (Procedure)
Group PENG
The investigators performed a pericapsular nerve block on that patient group for postoperative analgesia.
干预措施: Bupivacaine Hydrochloride (Drug)
Group SSNB
The investigators performed a suprascapular nerve block on that patient group for postoperative analgesia.
干预措施: Suprascapular nerve block (Procedure)
Group SSNB
The investigators performed a suprascapular nerve block on that patient group for postoperative analgesia.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
时间窗: 36 hours postoperatively
Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 30, and 36th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Postoperative 36-hour total tramadol hydrochloride consumption(36 hours postoperatively)
研究者
Gokhan Sertcakacilar, MD
Principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital