Trial of Extended Release Bupivacaine for Pain Relief After Surgery
PERSIST
A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)
1 other identifier
interventional
399
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2015
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
July 13, 2021
CompletedJuly 13, 2021
June 1, 2021
1.6 years
October 9, 2015
March 3, 2021
June 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Assessed from 0 to 48 hours post-dose, summary measure (see description) reported.
Secondary Outcomes (6)
Pain Intensity Using the NPRS-11 With Movement
Assessed from 0 to 72 hours post-dose, summary measure (see description) reported.
Total IV Morphine-equivalent Dose of Rescue Opioids
0-72 hrs. post dose (after surgery)
Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score
0 to 72 hours
Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours
From PACU Discharge to 72 Hours post-treatment
Time to First Opioid Rescue Medication Use After Discharge From the PACU
From PACU Discharge to 72 Hours post-treatment
- +1 more secondary outcomes
Study Arms (2)
Part 1
PLACEBO COMPARATORSABER-Bupivacaine and Saline Placebo
Part 2
ACTIVE COMPARATORSABER-Bupivacaine and Bupivacaine HCl
Interventions
5 ml once at end of surgery
5 ml once at end of surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Durectlead
Study Sites (21)
Durect Study Site 04
Florence, Alabama, 35360, United States
Durect Study Site 03
Sheffield, Alabama, 35660, United States
DURECT Study Site 24
Arcadia, California, 91007, United States
Durect Study Site 15
Fontana, California, 92335, United States
Durect Study Site 02
Laguna Hills, California, 92653, United States
Durect Study Site 18
Laguna Hills, California, 92653, United States
Durect Study Site 22
Pensacola, Florida, 32503, United States
Durect Study Site 12
Indianapolis, Indiana, 46202, United States
Durect Study Site 21
Royal Oak, Michigan, 48073, United States
Durect Study Site 17
Jackson, Mississippi, 39202, United States
Durect Study Site 16
Las Vegas, Nevada, 89104, United States
Durect Study Site 20
Las Vegas, Nevada, 89109, United States
Durect Study Site 05
Stony Brook, New York, 11794, United States
Durect Study Site 13
Durham, North Carolina, 27710, United States
Durect Study Site 09
Cleveland, Ohio, 44106, United States
Durect Study Site 11
Cleveland, Ohio, 44111, United States
Durect Study Site 07
Cleveland, Ohio, 44195, United States
Durect Study Site 14
Philadelphia, Pennsylvania, 19107, United States
Durect Study Site 08
Houston, Texas, 77004, United States
DURECT Study Site 01
Houston, Texas, 77043, United States
Durect Study Site 23
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Deborah Scott
- Organization
- Durect Corporation
Study Officials
- STUDY DIRECTOR
Dave Ellis, MD
Durect
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 14, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
July 13, 2021
Results First Posted
July 13, 2021
Record last verified: 2021-06