A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 399
- 试验地点
- 21
- 主要终点
- Pain Intensity on Movement From 0-48 Hours Post-Treatment
研究概览
简要总结
This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.
The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective outpatient laparoscopic cholecystectomy using a conventional 4-port laparoscopic procedure.
- •Must be able and willing to provide written informed consent, complete trial-related procedures, and communicate with the trial staff.
- •Males and females 18 years of age or older.
- •ASA Class I, II, or III.
- •Patients of child-bearing potential must agree to use a medically acceptable method of contraception to prevent pregnancy for the duration of their participation in the trial.
- •Must be living close enough to the investigative site to attend the four scheduled follow-up clinic visits.
排除标准
- •Pregnant or nursing females.
- •Patients with absolute or relative contraindications to laparoscopic cholecystectomy.
- •Patients with prior midline abdominal surgery who are at risk for adhesions that may complicate laparoscopic cholecystectomy and/or accurate pain assessments.
- •Patients requiring emergency surgery or urgent surgery (fewer than 5 days between screening and surgery).
- •Patients with a pre-planned overnight stay or pre-planned hospital admission.
- •Patients scheduled for single incision, mini trocars, natural orifice transluminal endoscopic surgery (NOTES), robotic laparoscopic procedures, or any procedure (other than cholangiograms and minimal adhesiolysis) in addition to laparoscopic cholecystectomy.
- •Patients with known hypersensitivity to amide local anesthetics such as bupivacaine.
- •Patients with acute pain that is not due to cholecystitis.
- •Patients with a history of chronic pain unrelated to gallbladder disease.
- •Patients with ongoing depression or psychosis.
- •Patients undergoing long-term treatment with opioids or other analgesics, including acetaminophen, NSAIDs, anticonvulsants (gabapentin or pregabalin), and antidepressants (SSRIs, SNRIs, and tricyclics), but not including daily low-dose aspirin.
- •Patients who are being treated chronically with systemic corticosteroids or who will require peri-operative corticosteroids because of adrenal insufficiency (inhalational or topical corticosteroids are permitted).
- •Patients who may be unsuitable for opioid administration (such as sensitivity [e.g., history of severe nausea and vomiting] hypersensitivity, known history of abuse or addiction, or unwillingness to take prescribed rescue opioids).
- •Use of anticoagulants and antiplatelet drugs (with exception of low dose aspirin) in the 1 week prior to surgery.
- •Patients who are incapable of operating the electronic diary.
- •Patients participating in any other trial with an investigational drug or device concurrently or less than 30 days prior to surgery for this trial.
- •Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial procedures for any reason.
研究组 & 干预措施
Part 1
SABER-Bupivacaine and Saline Placebo
干预措施: SABER-Bupivacaine (Part 1) (Drug)
Part 1
SABER-Bupivacaine and Saline Placebo
干预措施: Saline Placebo (Drug)
Part 2
SABER-Bupivacaine and Bupivacaine HCl
干预措施: SABER-Bupivacaine (Part 2) (Drug)
Part 2
SABER-Bupivacaine and Bupivacaine HCl
干预措施: Bupivacaine HCl (Drug)
结局指标
主要结局
Pain Intensity on Movement From 0-48 Hours Post-Treatment
时间窗: Assessed from 0 to 48 hours post-dose, summary measure (see description) reported.
A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 13 planned time points from 0 to 48 hours post-treatment. The values reported are mean pain scores for each treatment group.
次要结局
- Pain Intensity Using the NPRS-11 With Movement(Assessed from 0 to 72 hours post-dose, summary measure (see description) reported.)
- Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours(From PACU Discharge to 72 Hours post-treatment)
- Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score(0 to 72 hours)
- Total IV Morphine-equivalent Dose of Rescue Opioids(0-72 hrs. post dose (after surgery))
- Time to First Opioid Rescue Medication Use After Discharge From the PACU(From PACU Discharge to 72 Hours post-treatment)
- Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS)(From admission to discharge from PACU (Approximately 0 to 12 hours))