Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Total Opioid Pain Medications Required Through 3-24h Post op in MME
研究概览
简要总结
Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.
详细描述
Material and Methods:
This is a prospective cohort study with historical controls. Cases of those receiving a non-opioid multimodal pain regimen will be compared to historical controls of those receiving a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325 grams will be included in this study. Multimodal pain regimen will include the following:
Protocol:
Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
- •Uterine weight ≤325 grams
排除标准
- •contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
- •current opioid prescription
研究组 & 干预措施
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Gabapentin (Drug)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Acetaminophen (Drug)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Celecoxib (Drug)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Ketorolac (Drug)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Paracervical block with ropivacaine (Procedure)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites (Procedure)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Hydromorphone (Drug)
Prospective cohort
Pre-Op:
- Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
- Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
- Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
- Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
- Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
- At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
- Gabapentin 300mg PO BID for 7 days
- Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
- Celecoxib 200mg PO q 12h x 7d
- Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
干预措施: Oxycodone (Drug)
Historical Control
Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Total Opioid Pain Medications Required Through 3-24h Post op in MME
时间窗: 3-24 hours after surgery
Total opioid pain medications required through 3-24h post op in MME
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
时间窗: 0-3 hours after surgery
Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
次要结局
- Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period(0-14 days)
- Estimated Blood Loss(0-300 minutes)
- Pain Scores(0-3 hours after surgery)
- Operative Time(0-300 minutes)
- Length of Stay in Hours(0- 240 hours)
研究者
Sarah Andres, D.O.
Principal Investigator
State University of New York at Buffalo