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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
399
Durect Study Site 04
Florence, Alabama, United States
Durect Study Site 03
Sheffield, Alabama, United States
Pain Intensity on Movement From 0-48 Hours Post-Treatment
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.
Time frame: Assessed from 0 to 48 hours post-dose, summary measure (see description) reported.
Pain Intensity Using the NPRS-11 With Movement
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 17 planned time points from 0 to 72 hours post-treatment. The values reported are mean pain scores for each treatment group.
Time frame: Assessed from 0 to 72 hours post-dose, summary measure (see description) reported.
Total IV Morphine-equivalent Dose of Rescue Opioids
IV morphine-equivalent dose
Time frame: 0-72 hrs. post dose (after surgery)
Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score
Score of Integrated Analgesia (SIA) is a composite endpoint that integrates pain assessment scores with opioid use over various collections of timepoints by ranking the pain score and the opioid use separately across treatments. After the scores are computed the means are calculated across time points to provide a single overall treatment effect. The composite SIA score ranges from -200 to 200 with -200 being the best case and 200 the worst case.
Time frame: 0 to 72 hours
Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours
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0.5%, 15 ml, once at end of surgery
DURECT Study Site 24
Arcadia, California, United States
Durect Study Site 15
Fontana, California, United States
Durect Study Site 02
Laguna Hills, California, United States
Durect Study Site 18
Laguna Hills, California, United States
Durect Study Site 22
Pensacola, Florida, United States
Durect Study Site 12
Indianapolis, Indiana, United States
Durect Study Site 21
Royal Oak, Michigan, United States
Durect Study Site 17
Jackson, Mississippi, United States
...and 11 more locations
Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl
Time frame: From PACU Discharge to 72 Hours post-treatment
Time to First Opioid Rescue Medication Use After Discharge From the PACU
Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl
Time frame: From PACU Discharge to 72 Hours post-treatment
Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS)
mPADSS is a tool used to determine eligibility for discharge from the PACU after ambulatory surgery. It includes an assessment of parameters such as vital signs, activity level, nausea/vomiting, pain, and surgical bleeding. For this trial, evaluation of eligibility for PACU discharge by mPADSS has been slightly modified to provide a standardized means of assessing eligibility for PACU discharge across multiple investigative sites and also ensures that nonmedical complications, such as a missing ride home, do not interfere with evaluation of test drug effects.
Time frame: From admission to discharge from PACU (Approximately 0 to 12 hours)