Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in STP as assessed by Numeric Rating Scale (NRS-11), from before to after the treatment in the PACU after receiving a 30-minute unilateral SPG block or bilateral SPG block
研究概览
简要总结
The purpose of this study is to determine the efficacy of sphenopalatine ganglion (SPG) block to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision, band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. Shoulder tip pain (STP) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic analgesics including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not reliably relieve STP. This study is designed to determine if the SPG block, a simple and low-risk procedure, effectively treats STP after laparoscopic bariatric surgery.
详细描述
This is a randomized, placebo-controlled, parallel group prospective, double-blind study. The primary outcome variable will be change in STP from > 4 before to after treatment in the PACU after primary laparoscopic gastric banding, band revision, band replacement, sleeve gastrectomy, or revision of sleeve gastrectomy. Investigators hope to achieve a decline in STP in 2 units after treatment.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective primary laparoscopic gastric banding surgery.
- •Laparoscopic band revision surgery
- •Laparoscopic band replacement surgery.
- •Sleeve gastrectomy.
- •Revision of sleeve gastrectomy.
- •American Society of Anesthesiologists Class 2 or
- •No allergy to study drugs.
- •Facility with English language to allow compliance with study protocol.
排除标准
- •American Society of Anesthesiologists Class 4 or
- •Allergy to lidocaine or to any local anesthetic
- •Allergy to oxymetazoline (Afrin)
- •Pregnancy
- •Bleeding diathesis
- •Known nasal pathology including active sinusitis
- •Previous nasal surgery
- •Preoperative anticoagulant use OTHER THAN aspirin 81 mg and/or heparin 5000 U SQ bid administered for DVT prophylaxis.
- •Acute psychiatric disease
- •History of chronic right or left shoulder pain
- •Current opioid use
- •Any patient that the study team feels will be unable to comply with all protocol related procedures
- •Concurrent participation in another clinical trial
研究组 & 干预措施
4% lidocaine
10 mL vials filled with 4% lidocaine or normal saline (50 vials of each solution) and pharmacist will code the vials from 1 to 100 using a computer-generated randomization scheme.
干预措施: 4% Lidocaine (Drug)
Placebo Saline
10 mL vials filled with 4% lidocaine or normal saline (50 vials of each solution) and pharmacist will code the vials from 1 to 100 using a computer-generated randomization scheme.
干预措施: Saline (Other)
结局指标
主要结局
Change in STP as assessed by Numeric Rating Scale (NRS-11), from before to after the treatment in the PACU after receiving a 30-minute unilateral SPG block or bilateral SPG block
时间窗: Baseline, 30 Minutes
subject will be asked to rate her/his pain from zero to ten with zero being "no pain" to ten being "the worst pain imaginable."
次要结局
未报告次要终点