Epidural Analgesia verSus Opioid-sparing analgEsia Protocol for Pain Control Following Open Ventral Hernia Repair With Transversus Abdominis Release: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of Postoperative Pain Scores
研究概览
简要总结
This study is comparing two ways to manage pain after a major hernia repair surgery called "transversus abdominis release." One method uses an epidural, a small tube placed in the back that delivers pain medicine directly around the spine. The other method avoids the epidural and instead uses a combination of non-opioid pain medicines, along with an injection of numbing medicine into the abdominal wall during surgery. Patients who still have pain that is hard to control with either method will be given rescue pain medicine through an intravenous (IV) pump.
Researchers want to learn which method controls pain better and results in patients using fewer opioid pain medicines after surgery. Participants will be randomly assigned (like a coin flip) to one of the two pain control methods. Pain levels and medication use will be tracked during the hospital stay, and participants will be contacted 30 days after surgery to check on recovery and any side effects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥18 years old
- •Symptomatic incisional ventral or parastomal hernias
- •Planned transversus abdominis release
- •Ability to provide informed consent
排除标准
- •Contraindications to epidural placement
- •Chronic pre-operative opioid use, defined as daily opioid use for 30-days prior to surgery
- •Allergy or intolerance to study medications
- •Age greater than 80 years
- •Impaired renal function - defined as creatinine clearance or estimated GFR of <60ml/min
- •Planned ICU admissions with post-operative intubation
- •Urgent or emergent presentations
- •Adults unable to consent
- •Pregnant patients
研究组 & 干预措施
Epidural Analgesia
Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine/fentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed.
干预措施: Bupivicaine (Drug)
Epidural Analgesia
Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine/fentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed.
干预措施: Thoracic epidural analgesia (Device)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: transversus abdominis plane block (Procedure)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: magnesium sulfate (Drug)
Epidural Analgesia
Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine/fentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed.
干预措施: Fentanyl (Drug)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: Hydromorphone (Drug)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: Ketorolac (Drug)
Epidural Analgesia
Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine/fentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed.
干预措施: Hydromorphone (Drug)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: Acetaminophen (Drug)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: Gabapentin (Drug)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: Tramadol (Drug)
Opioid-Sparing Multimodal Analgesia
Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control.
干预措施: Cyclobenzaprine (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of Postoperative Pain Scores
时间窗: Postoperative Day 1 through Postoperative Day 4
Postoperative pain will be measured using the Numeric Rating Scale (NRS, 0-10) at standardized 6-hour intervals over the first four postoperative days. The area under the curve of these serial measurements will be calculated to reflect cumulative postoperative pain burden.
次要结局
- Total Postoperative Opioid Consumption(Through hospital discharge, an average of 5 days)
- Length of Hospital Stay(Through hospital discharge, an average of 5 days)
- Incidence of Postoperative Ileus(Through hospital discharge, an average of 5 days)
- Incidence of Epidural-Related Complications(Through hospital discharge, an average of 5 days)
- Patient Satisfaction with Pain Management (Binary)(At hospital discharge)
- 30-Day Postoperative Complications(30 days (± 15 days) postoperatively)
- 30-Day Postoperative Opioid Prescribing and Consumption(30 days (± 15 days) postoperatively)
- Patient Satisfaction with Pain Management (Numeric Scale)(At hospital discharge)
- Daily Average Numeric Rating Scale Pain Score(Postoperative Day 1 through Postoperative Day 4)
研究者
Megan Melland-Smith
Assistant Professor
Northwestern University