Comparing the Analgesic Effects of Ultrasonography-guided and Direct-surgical Rectus Sheath Block in Single-port Access Laparoscopy Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- The intensity of pain as assessed by Dose of fentanyl(opioid)
研究概览
简要总结
Rectus sheath block is effective in reducing pain in the peri-umbilical region, and the use of ultrasonography is recommended to perform the block at the precise location. Recently, intra-operative rectus sheath block has also been introduced without the aid of ultrasonography. However, no study has not yet compared the analgesic effects of these two different approaches (ultrasonography-guided vs direct surgical). Thus, the aim of our study is to compare the effect of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.
详细描述
This is a randomized, prospective study comparing the analgesic effects of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.
Patients will be randomly divided into 3 groups based on the procedure: control group, ultrasonography group and direct injection group. Each group consists of 30 patients.
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Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
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Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.
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Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for a single port laparoscopic surgery at Chung Nam University hospital due to benign tumor of the ovary or the fallopian tube
- •Between age of twenty to seventy
- •Patients with a physical rating of 1 or 2 according to the American Anesthesiology guidelines
- •Patients who have not had laparoscopic surgery within two months
排除标准
- •Hysterectomy via single port laparoscopic surgery
- •Patients with chronic pelvic pain
- •Abdominal pain of unknown origin
- •Suspected malignant tumor
- •Diagnosed with malignant tumor of any origin
- •Patients currently taking psychiatric medicine
- •Patients with a history of hypersensitivity to amide type local anesthetics
- •Patients with a history of hypersensitivity to opioid
- •Risk of bleeding
- •Unable to comprehend or does not agree to the consent form
研究组 & 干预措施
Group 3, Direct injection group
Test group 2, Rectus sheath block will be performed under direct visualization. Ropivacaine (0.75%, 10ml) will be directly injected into the right and left rectus sheath at the end of the operation.
干预措施: Rectus sheath block (Procedure)
Group 3, Direct injection group
Test group 2, Rectus sheath block will be performed under direct visualization. Ropivacaine (0.75%, 10ml) will be directly injected into the right and left rectus sheath at the end of the operation.
干预措施: Ropivacaine (Drug)
Group 2, ultrasonography group
Test group 1, Rectus sheath block will be performed under sonographic guidance. Ropivacaine (0.75%, 10ml) will be injected into the right and left rectus sheath under ultrasonographic guidance at the end of the operation.
干预措施: Rectus sheath block (Procedure)
Group 2, ultrasonography group
Test group 1, Rectus sheath block will be performed under sonographic guidance. Ropivacaine (0.75%, 10ml) will be injected into the right and left rectus sheath under ultrasonographic guidance at the end of the operation.
干预措施: Ropivacaine (Drug)
Group 1
Control group, Rectus sheath block will be performed under sonographic guidance. Normal saline 10 ml will be injected into the right, left rectus sheath under ultrasonography guidance at the end of the operation.
干预措施: Rectus sheath block (Procedure)
Group 1
Control group, Rectus sheath block will be performed under sonographic guidance. Normal saline 10 ml will be injected into the right, left rectus sheath under ultrasonography guidance at the end of the operation.
干预措施: Normal saline (Other)
结局指标
主要结局
The intensity of pain as assessed by Dose of fentanyl(opioid)
时间窗: within 24 hours of surgery
Dose of fentanyl(opioid) self-administered by the patients within 24 hours of surgery
次要结局
- Incident rate of side effects of fentanyl(within 24 hours of surgery)
研究者
Heon-Jong Yoo
Clinical Vice professor
Chungnam National University Hospital