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Trial of Extended Release Bupivacaine for Pain Relief After Surgery (PERSIST)

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ClinicalTrials.gov Identifier: NCT02574520
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Durect

Brief Summary:

This is a research study of SABER® -Bupivacaine, an experimental medication designed to relieve 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).


Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: SABER®-Bupivacaine Drug: Bupivacaine HCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Trial (Part 1) or Active-controlled (Part 2) of SABER® Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy
Actual Study Start Date : November 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SABER®-Bupivacaine
Extended Release Solution for instillation; SABER®-Bupivacaine /Once
Drug: SABER®-Bupivacaine
Active Comparator: Bupivacaine HCl
Solution for infiltration; Bupivacaine HCl/Once
Drug: Bupivacaine HCl



Primary Outcome Measures :
  1. Pain intensity using the NPRS-11 with movement [ Time Frame: 0 to 48 hours post-dose ]
    Pain will be rated when subjects sit up from a supine position


Secondary Outcome Measures :
  1. Pain intensity using the NPRS-11 with movement [ Time Frame: 0 to 72 hours post-dose ]
  2. Total IV morphine-equivalent dose of rescue opioids [ Time Frame: 0 to 72 hours ]
  3. Composite endpoint of Silverman's Integrated Analgesic (SIA) assessment score [ Time Frame: 0 to 72 hours ]
  4. Proportion of patients taking no opioid rescue medication from PACU discharge [ Time Frame: 0 to 72 hours ]
  5. Time to first opioid rescue medication use after discharge from the PACU [ Time Frame: 0 to 72 hours ]
  6. Time to PACU discharge eligibility as assessed by modified Post-Anesthesia Discharge Scoring System (mPADSS) [ Time Frame: 0 to 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574520


Locations
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United States, Alabama
Durect Study Site 04
Florence, Alabama, United States, 35360
Durect Study Site 03
Sheffield, Alabama, United States, 35660
United States, California
DURECT Study Site 24
Arcadia, California, United States, 91007
Durect Study Site 15
Fontana, California, United States, 92335
Durect Study Site 02
Laguna Hills, California, United States, 92653
Durect Study Site 18
Laguna Hills, California, United States, 92653
United States, Florida
Durect Study Site 22
Pensacola, Florida, United States, 32503
United States, Indiana
Durect Study Site 12
Indianapolis, Indiana, United States, 46202
United States, Michigan
Durect Study Site 21
Royal Oak, Michigan, United States, 48073
United States, Mississippi
Durect Study Site 17
Jackson, Mississippi, United States, 39202
United States, Nevada
Durect Study Site 16
Las Vegas, Nevada, United States, 89104
Durect Study Site 20
Las Vegas, Nevada, United States, 89109
United States, New York
Durect Study Site 05
Stony Brook, New York, United States, 11794
United States, North Carolina
Durect Study Site 13
Durham, North Carolina, United States, 27710
United States, Ohio
Durect Study Site 09
Cleveland, Ohio, United States, 44106
Durect Study Site 11
Cleveland, Ohio, United States, 44111
Durect Study Site 07
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Durect Study Site 14
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Durect Study Site 08
Houston, Texas, United States, 77004
DURECT Study Site 01
Houston, Texas, United States, 77043
Durect Study Site 23
Plano, Texas, United States, 75093
Sponsors and Collaborators
Durect
Investigators
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Study Director: Dave Ellis, MD Durect

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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT02574520     History of Changes
Other Study ID Numbers: C803-028
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Durect:
Post-operative pain
opioid
opioid reduction
laparoscopic cholecystectomy
laparoscopic surgery
bupivacaine
extended release
locally acting analgesic
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents