Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia.
详细描述
152 women will be randomized into one of two arms; participants in the first arm (Intervention) will receive oxytocin infusion, 30 IU in 500 ml IV infusion at a rate of 5 IU/h (83.33 ml/h), the second arm (Control) will receive 0.9% normal saline 500 ml IV infusion at the same rate of 83.3 ml/h. The primary care team (anesthesia, surgery, and nursing), the research team, and the patient will all be blinded to the research arm.
The investigational research pharmacy will perform randomization; participants will be randomized in a 1:1 ratio to receive either Oxytocin or Placebo (0.9% normal saline). Randomization will be blinded to investigators to prevent bias and ensure balance in treatment arms throughout the study. Participants, surgeons, clinicians, and raters will be blinded with respect to treatment assignments. The investigational pharmacy will prepare the study drug based on the randomization assignment received.
The investigators will identify patients who have been scheduled for an elective, minimally invasive hysterectomy at Brigham and Women's Hospital by reviewing the operating room booking schedule.
Patients will be pre-screened for inclusion and exclusion criteria. Subsequently, they will be recruited for participation in this study by phone/ MGB Zoom and will be consented by electronic consent.
Once the patient is recruited and consented, they will be randomized for either the intervention group (oxytocin IV infusion) or the control group (0.9% normal saline IV infusion).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization of the study medication will be performed by the investigational drug pharmacy and the unblinded key will be stored in a secure location in the pharmacy.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 18-65 years old
- •ASA category 1-3
- •Scheduled to undergo minimally invasive hysterectomy
- •No documented allergy to oxytocin
排除标准
- •American Society of Anesthesiologists (ASA) group 4 or greater
- •Age >65 years old
- •Additional surgical procedures including but not limited to minor laparotomy, omentectomy, cystectomy, vaginectomy, and/or ablation of endometriosis.
- •Active opioid prescription of the equivalent of oxycodone >10 mg /day
- •Opioid use disorder, including patients in treatment receiving naltrexone or Suboxone (Buprenorphine-naloxone)
- •Allergies to any study medication: acetaminophen, celecoxib, ketorolac, fentanyl, hydromorphone, or oxycodone.
- •Epidural/Regional anesthesia for intra-operative or post-operative pain.
- •Inability to understand the questionnaires
- •Intra-operative and post-operative exclusion: Procedure converted to open or extension of primary surgery, Intra-operative EBL >500 ml., Placement of epidural catheter or regional anesthesia at PACU for pain management, Hospitalization of the patient due to surgical or anesthetic complications
研究组 & 干预措施
Placebo
one group will receive 500 ml of 0.9% normal saline
干预措施: Placebo (Drug)
Medication
one group will receive Oxytocin infusion: 30 IU in 500 ml of 0.9% normal saline .
干预措施: Oxytocin (Drug)
结局指标
主要结局
Post-operative pain
时间窗: Between 2-4 hours after surgery completion (in the PACU)
Assess the impact of a perioperative infusion of oxytocin on postoperative pain, the average patient pain scores measured as a mean Brief Pain Inventory in PACU after laparoscopic hysterectomy in treated and untreated groups will be compared
次要结局
- Perioperative opioid consumption(From start of infusion until approximately 6 hour mark (infusion completion))
- POD1 Opioid consumption(In the first 24 hours after surgery)
- POD3 Opioid consumption(From 48-72 hours after surgery)
- PACU satisfaction scores(Between 2-4 hours after surgery completion (in the PACU))
- POD1 satisfaction scores(On Post-operative day 1)
- POD2 satisfaction scores(On Post-operative day 2)
- POD3 satisfaction scores(On Post-operative day 3)
- PACU Post-operative pain(Between 2-4 hours after surgery completion (in the PACU))
- POD1 Post-operative pain(On Post-operative day 1)
- POD2 Post-operative pain(On Post-operative day 2)
- POD2 Opioid consumption(From 24-48 hours after surgery)
- POD3 Post-operative pain(On Post-operative day 3)
- Intraoperative hypotension (# of episodes of MAP <60 mmHg)(Through surgery completion, an average of 2 hours (From start of infusion to completion end of time in the operating room))
- PACU hypotension (# of episodes of MAP <60 mmHg)(Between 0-4 hours after surgery completion (in the PACU))
研究者
John J. Kowalczyk, MD
Director of Fellowship Research
Brigham and Women's Hospital