A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Numeric post-operative pain score
研究概览
简要总结
The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.
The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.
详细描述
This study is designed as a non-inferiority trial comparing a non-opioid post-operative pain control regimen to the standard opioid pain control regimen for post-operative salpingectomy patients. A non-inferiority margin of 2 units was selected, such that the experimental treatment will be considered non-inferior if the lower bound of the confidence interval for the treatment difference remains above a 2 point difference in reported pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals with a fallopian tube (unilateral and/or bilateral)
- •Age 18 years old and above
- •Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
- •Benign indications for salpingectomy/tubal sterilization
- •Agreeing to participate
排除标准
- •Chronic pain syndromes patients including fibromyalgia
- •Patients currently on long-term (i.e. for more than three months) opioid use
- •Conversion to laparotomy
- •Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
- •Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
- •Salpingectomy performed for treatment of ectopic pregnancy
- •Patients with a history of gastritis and/or GI bleeding
研究组 & 干预措施
Arm 1 - Opioid Post-Op Pain Regimen
Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge.
These medications include:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter
干预措施: Acetaminophen (Drug)
Arm 1 - Opioid Post-Op Pain Regimen
Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge.
These medications include:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter
干预措施: Ibuprofen (Drug)
Arm 1 - Opioid Post-Op Pain Regimen
Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge.
These medications include:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter
干预措施: Oxycodone (Drug)
Arm 2 - Non-Opioid Post-Op Pain Regimen
Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter.
Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.
干预措施: Ibuprofen (Drug)
Arm 2 - Non-Opioid Post-Op Pain Regimen
Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter.
Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Numeric post-operative pain score
时间窗: post-operative day 1 and post-operative day 7
Patient reported pain on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" using the Likert pain scale from 0 to 10, where 0 is no pain and 10 is severe pain. A higher score indicates a worse outcome.
次要结局
- Satisfaction with post-operative pain relief(post-operative day 1 and post-operative day 7)
- Satisfaction with post-operative mobility(post-operative day 1 and post-operative day 7)
- Total narcotic consumption at one week post-operative(post-operative day 7)
- Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)(post-operative day 1 and post-operative day 7)
- Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern(Within 30 days of surgery)