A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)
Overview
- Phase
- Phase 3
- Intervention
- SABER-Bupivacaine (Part 1)
- Conditions
- Post Operative Pain
- Sponsor
- Durect
- Enrollment
- 399
- Locations
- 21
- Primary Endpoint
- Pain Intensity on Movement From 0-48 Hours Post-Treatment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Part 1
SABER-Bupivacaine and Saline Placebo
Intervention: SABER-Bupivacaine (Part 1)
Part 1
SABER-Bupivacaine and Saline Placebo
Intervention: Saline Placebo
Part 2
SABER-Bupivacaine and Bupivacaine HCl
Intervention: SABER-Bupivacaine (Part 2)
Part 2
SABER-Bupivacaine and Bupivacaine HCl
Intervention: Bupivacaine HCl
Outcomes
Primary Outcomes
Pain Intensity on Movement From 0-48 Hours Post-Treatment
Time Frame: 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.
Secondary Outcomes
- 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))