"ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- POD1 Visual Analog Pain (VAS) Score
研究概览
简要总结
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control compared to the standard narcotic based postoperative pain regimen in patients undergoing total laparoscopic gyn surgery.
详细描述
Laparoscopy is a frequently used route for hysterectomy. Yet few studies have investigated opioid-sparing postoperative regimens for this common surgery. The study objective was to determine whether ice packs, Tylenol, and Toradol (ICE-T), an opioid-sparing multimodal postoperative pain regimen, has improved pain control compared with a standard opioid-centric postoperative pain regimen in total laparoscopic hysterectomy patients.
The study was a randomized controlled trial. It included total laparoscopic hysterectomy postoperative patients that were randomized to the ICE-T or standard regimen. The ICE-T regimen prescribed scheduled around-the-clock ice-packs, acetaminophen and ketorolac. The standard protocol prescribed as needed ibuprofen and acetaminophen/oxycodone based on pain score. Both regimens included intravenous hydromorphone for breakthrough pain. However, subjects in the ICE-T group who requested additional narcotic medications prior to postoperative day 4, were prescribed supplemental narcotics in addition to the ICE-T regimen. The subjects pain control and quality of recovery were assessed on postoperative day 1 and 4.
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 (Participant)
盲法说明
The randomized sequence was masked to all except the statistician who developed the sequence. Upon randomization, the participants, care providers, investigators and outcome assessors were aware of the participant study arm allocations.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are the following:
- •Consenting, English speaking women between ages 18 and 80 who will undergo same day laparoscopic gyn surgery at MetroHealth Medical Center
- •Ability to read VAS Scores
- •Specific procedures include, but are not limited to:
- •Laparoscopic hysterectomy, for uterus 250 g or less
- •Laparoscopic hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s)
- •Laparoscopic hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele
- •Laparoscopic hysterectomy, for uterus 250 g or less; with repair of enterocele
- •Laparoscopic hysterectomy, for uterus greater than 250 g
- •Laparoscopic hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s)
- •Laparoscopic hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele
- •Laparoscopic hysterectomy, for uterus greater than 250 g; with repair of enterocele
排除标准
- •History of chronic pelvic pain
- •Abdominal surgery
- •History of psychiatric disease
- •Currently taking analgesic medications
- •Currently taking sedatives
- •Liver disease
- •Renal disease with CrCl < 60cc/min.
- •History of burns from application of ice.
- •Women who did not consent for the study.
- •Intraoperative concern for increased blood loss
- •Unable to speak English
- •Unable to understand VAS Scores
- •Undergoing concomitant abdominal procedures.
- •Allergy to motrin, toradol, Percocet, Tylenol
- •Active or history of peptic ulcer disease
- •History of GI bleeding or perforation
- •Hemorrhagic diathesis
- •Severe uncontrolled heart failure
- •Inflammatory bowel disease
研究组 & 干预措施
"ICE-T"
Regimen #1 "ICE-T" Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive
- ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (ATC) until discharge.
- 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
- Once out of the PACU will receive 1 gram of Tylenol per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge
- Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain.
- Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN).
- If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
干预措施: Ketorolac (Drug)
"ICE-T"
Regimen #1 "ICE-T" Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive
- ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (ATC) until discharge.
- 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
- Once out of the PACU will receive 1 gram of Tylenol per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge
- Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain.
- Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN).
- If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
干预措施: Opioids (Drug)
"ICE-T"
Regimen #1 "ICE-T" Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive
- ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (ATC) until discharge.
- 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
- Once out of the PACU will receive 1 gram of Tylenol per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge
- Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain.
- Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN).
- If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
干预措施: Ice Packs (Other)
"ICE-T"
Regimen #1 "ICE-T" Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive
- ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (ATC) until discharge.
- 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
- Once out of the PACU will receive 1 gram of Tylenol per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge
- Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain.
- Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN).
- If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
干预措施: Tylenol (Drug)
"ICE-T"
Regimen #1 "ICE-T" Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive
- ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (ATC) until discharge.
- 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
- Once out of the PACU will receive 1 gram of Tylenol per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge
- Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain.
- Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN).
- If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
干预措施: Dilaudid Injectable Product (Drug)
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen
- Once out of the PACU patients will receive "Standard" postoperative regimen
- Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain
- Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain
- Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain
- Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain.
- Patients will be discharged home with Motrin and Percocet for pain PRN.
干预措施: Opioids (Drug)
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen
- Once out of the PACU patients will receive "Standard" postoperative regimen
- Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain
- Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain
- Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain
- Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain.
- Patients will be discharged home with Motrin and Percocet for pain PRN.
干预措施: Motrin (Drug)
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen
- Once out of the PACU patients will receive "Standard" postoperative regimen
- Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain
- Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain
- Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain
- Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain.
- Patients will be discharged home with Motrin and Percocet for pain PRN.
干预措施: Dilaudid Injectable Product (Drug)
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen
- Once out of the PACU patients will receive "Standard" postoperative regimen
- Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain
- Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain
- Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain
- Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain.
- Patients will be discharged home with Motrin and Percocet for pain PRN.
干预措施: Percocet 5Mg-325Mg Tablet (Drug)
结局指标
主要结局
POD1 Visual Analog Pain (VAS) Score
时间窗: Morning of post operative day 1 (~24 hours after surgery)
Visual Analog Scores (VAS) Scores in the morning of post op day 1 (\~24 hours after surgery) The scale is from 0 to 10 (0=no pain and 10=being worst pain ever)
次要结局
- POD1 Quality of Recovery Score(Postoperative Day 1)
- 1st 24hr Total Dose of Narcotic(Total narcotic use from intra-op to 24 hours post-op)
- Length of Stay(Post-operative Day 1)
- POD4 VAS Scores(VAS Scores at 4 days post-surgery.)
- POD4 Quality of Recovery(Postoperative Day 4)
- POD4 Satisfaction Score(Data collected as of postoperative day 4)
- Time to First Bowel Movement(Up to post op day 4)
- Oxycodone 5mg Doses Taken Since Discharge(Data collected as of Postoperative day 4)
研究者
Robert Pollard, MD
Associate Professor of Reproductive Biology
MetroHealth Medical Center