The Effect of Exparel on Post Operative Pain and Narcotic Use After Colon Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- PCA (Patient Controlled Analgesia) Usage
研究概览
简要总结
The purpose of the study is to evaluate the effect of Exparel on pain control and patient outcome after colon resection. The investigators will evaluate the clinical course of the patients who receive exparel as compared to the patients who do not receive exparel. Exparel is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three days. A long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5 hour half-life.
详细描述
Patients who are undergoing elective colon resection with Dr. Kraemer and Dr. Raman will be offered participation in the study. This will include robotic, laparoscopic and open procedures.
In the pre-operative area prior to surgery, the surgical resident will inform the patient of the opportunity to participate in the research study. The resident will consent the patient at that time, if the patient chooses to participate, they will be randomized to an exparel or non-exparel group. The randomization will be done by having the resident pick an envelope that will state whether or not the patient is randomized to the exparel or non-exparel group, this will randomize to 50% in each group. The patient will not be notified of the type of local anesthetic they receive. The attending surgeon will also be blind to the type of local the pt will receive; only the resident and Operating Room (OR) staff will know what type of local anesthetic was given. Unfortunately the opaque color of the exparel precludes the physician injecting the local anesthetic from being blinded to the type of anesthetic given.
The patient will be taken to the operating room as usual, and the surgery will proceed as it normally would. At the end of the surgery the patient will receive either exparel or bupivacaine depending upon which the patient was randomized to. The attending surgeon will not be in the operating suite while the local anesthetic is being injected. 30 milliliters (mL) of either exparel or bupivacaine will be injected into the subcutaneous tissues at the end of surgery.
The patient will be taken to the post operative care unit (PACU), the medications for post-operative pain will be standardized between the two groups, a standard starting dose on the patient controlled analgesia (PCA) will be used, and will be adjusted as needed. The postoperative care will attempt to be standardized in regard to diet, discharge (dc) of foley, not using nasogastric (NG) tubes, however this will be based on the individual patient was what is best for their care. This data will then be analyzed to determine if exparel has a beneficial effect on surgical care.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective colon resection for both benign and malignant disease
- •Laparoscopic, robotic and open techniques
排除标准
- •emergent colon cases
- •cases preformed by surgeons other than Dr. Raman or Dr. Kraemer
- •pregnant patients
- •patients currently breast feeding
- •patients under the age of 18
- •other patients unable to give informed consent
- •bupivacaine use within 96 hours
- •allergy to amide anesthetics
- •prisoners
- •caution will be used in patients with renal or hepatic failure.
研究组 & 干预措施
Bupivacaine
30 milliliters (ml) of 0.5% marcaine with epinephrine
干预措施: Bupivacaine (Drug)
Bupivacaine liposome suspension
exparel 20ml, diluted with 10ml sterile saline for total of 30ml
干预措施: Bupivacaine liposome suspension (Drug)
结局指标
主要结局
PCA (Patient Controlled Analgesia) Usage
时间窗: 48 hours post operatively
Will measure the amount of PCA use for the first 48 hours after surgery.
次要结局
- Total Oral Narcotic Used(participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Length of Stay(participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Oral Pain Medications(48 hours postoperatively)
- Total IV (Intravenous) Narcotic Used(participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Return of Bowel Function(participants will be followed for the duration of hospital stay, an expected average of 3 days, and the timing of return of bowel function returning will be recorded)
- Readmission(30 days post operative readmission)
- Nausea Medication(The amount of nausea medicine used 48 hours post op was recorded)
- Foley Catheter Removal(participants will be followed for the duration of hospital stay, an expected average of 3 days, the timing of foley catheter removal will be recorded)
- Postoperative Pain(POD #3-5 and POD #13-15)
- Post Operative Satisfaction(POD #3-5 and POD #13-15)
- Toradol Use(participants will be followed for the duration of hospital stay, an expected average of 3 days)
- Ofirmev(participants will be followed for the duration of hospital stay, an expected average of 3 days, and the amount of ofirmev used during admission will be recorded)
- Home Oral Narcotic Use(POD #13-15)