Surgical Site Infiltration of Liposomal Bupivacaine Versus Transversus Plane Block With Liposomal Bupivacaine in Patients With Suspected or Known Gynecologic Cancer Undergoing Laparotomy Via Midline Incision
试验速览
- 阶段
- 4 期
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Total postoperative opioid consumption over 48 hours
研究概览
简要总结
This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or known gynecologic malignancies undergoing midline laparotomy who received TAP block with liposomal bupivacaine versus surgical site infiltration of liposomal bupivacaine.
Primary outcome: Total postoperative opioid consumption as measured by morphine equivalents over 48 hour period.
Secondary outcomes include: Pain scores (based on visual analog scale 1-10) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively at rest and upon exertion (Valsalva maneuver), Severity of nausea, Episodes of vomiting, Total antiemetics consumption over 48 hour period.
详细描述
Recent studies suggest surgical site infiltration of local anesthetic into the preperitoneal, subfascial and/or subcutaneous planes as an alternative approach. The literature suggests this offers superior pain relief and significantly reduced morphine consumption. This procedure has been shown to provide excellent analgesia in open inguinal hernia repair and colorectal procedures up to 72 hours after a single injection. However, there is limited published data comparing TAP block with liposomal bupivacaine and surgical site infiltration of liposomal bupivacaine in open hysterectomy patients.
The investigators propose to prospectively study the efficacy of surgical site infiltration of liposomal bupivacaine versus TAP block with liposomal bupivacaine in patients with suspected or known gynecologic malignancies undergoing midline laparotomy. The investigators hypothesize that surgical site infiltration of liposomal bupivacaine is more effective than TAP block with liposomal bupivacaine in this patient population. The investigators primary outcome will be postoperative total 48 hour opioid consumption.
Secondary outcomes will include visual analog scale (VAS) pain scores at rest and upon exertion (Valsalva maneuver) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively, severity of nausea, episodes of vomiting and total antiemetics consumption postoperatively. Pain scores and severity of nausea scores will be collected in person or over the phone.
The investigators expect the results of this study to demonstrate that surgical site infiltration of liposomal bupivacaine in patients with suspected or known gynecologic malignancies undergoing midline laparotomy may help shorten the recovery period and reduce the need for postoperative opioid medications. Furthermore, generally patients undergoing procedures such as tumor debulking and lymph node dissection would have an extended hospitalization. If surgical site infiltration of liposomal bupivacaine administration is found to decrease the length of hospitalization (versus TAP Block with liposomal bupivacaine), it will significantly decrease the health care costs.
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
- Single (Participant)
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
- •Any woman age 18 or over with known or suspected gynecologic malignancy who is scheduled for laparotomy via vertical midline incision at Danbury Hospital or Norwalk Hospital
- •American Society of Anesthesiologists physical status I to IV (a normal healthy patient to a patient with severe systemic disease that may be constant threat to life)
- •English or Spanish speaking
排除标准
- •Pregnancy
- •Unable to obtain consent
- •Severe allergies and/or anaphylaxis to bupivacaine or other anesthetics of the same class, to hydromorphone or morphine equivalents
- •Patients taking fospropofol, hyaluronidase, propofol, propranolol, St John's Wort and verapamil at the time of screening
- •Significant psychiatric disturbance as recorded in the medical record
- •Current or history of alcohol or drug addiction
- •Have current acute or chronic pain disorders as indicated in medical record
- •Current or history of opioid dependence
- •Contraindications to acetaminophen (significant hepatic dysfunction or disease), ketorolac and ibuprofen (significant renal dysfunction or reactive airway disease)
- •≥2 previous midline laparotomies
研究组 & 干预措施
TAP block with Exparel
Patients will receive immediate postoperative bilateral 2-quadrant TAP block with Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by the anesthesia team.
干预措施: TAP Block (Procedure)
TAP block with Exparel
Patients will receive immediate postoperative bilateral 2-quadrant TAP block with Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by the anesthesia team.
干预措施: Exparel (Drug)
Surgical Site Infiltration of Exparel
Patients will receive surgical site infiltration of Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by surgeon.
干预措施: Surgical Site Infiltration (Procedure)
Surgical Site Infiltration of Exparel
Patients will receive surgical site infiltration of Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by surgeon.
干预措施: Exparel (Drug)
结局指标
主要结局
Total postoperative opioid consumption over 48 hours
时间窗: over 48 hour period after surgery
Total postoperative opioid consumption as measured by morphine milligram equivalents (MME)
次要结局
- Pain scores at rest and upon exertion(2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively)
- Severity of nausea(2, 6, 12, 24, & 48 hours postoperatively)
- Episodes of vomiting(48 hours postoperatively)
- Total antiemetics consumption(48 hour postoperatively)
研究者
Linus Chuang
Network Chairman OB/GYN
Danbury Hospital