Trial of Extended Release Bupivacaine for Pain Relief After Surgery



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:5/27/2018
Start Date:November 2015
End Date:August 2017

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A Placebo-controlled Trial (Part 1) or Active-controlled (Part 2) of SABER® Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy

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).


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.
We found this trial at
19
sites
Stony Brook, New York 11794
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Stony Brook, NY
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Arcadia, California 91007
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Arcadia, CA
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Cleveland, Ohio 44106
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Cleveland, OH
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Cleveland, Ohio 44106
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Cleveland, OH
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Cleveland, Ohio 44106
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Cleveland, OH
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Durham, North Carolina 27710
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Durham, NC
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Florence, Alabama 35360
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Florence, AL
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Fontana, California 92335
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Fontana, CA
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Houston, Texas 77043
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Houston, TX
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Houston, Texas 77043
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jackson, Mississippi 39202
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Jackson, MS
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Laguna Hills, California 92653
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Laguna Hills, CA
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Las Vegas, Nevada 89104
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Las Vegas, NV
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Pensacola, Florida 32503
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Pensacola, FL
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Plano, Texas 75093
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Plano, TX
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Royal Oak, Michigan 48073
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Royal Oak, MI
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Sheffield, Alabama 35660
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Sheffield, AL
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