Clinical trial NCT02574520: Trial of Extended Release Bupivacaine for Pain Relief After Surgery
Official title: A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: Post-operative pain
non-opioid analgesic
opioid reduction
laparoscopic cholecystectomy
laparoscopic surgery
bupivacaine
extended release
locally acting analgesic
Lead sponsor: Durect
Sponsor class: INDUSTRY
First posted: 2015-10-14
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
* 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.

Primary outcomes:
measure: Pain Intensity on Movement From 0-48 Hours Post-Treatment
timeFrame: Assessed from 0 to 48 hours post-dose, summary measure (see description) reported.
Secondary outcomes:
measure: Pain Intensity Using the NPRS-11 With Movement
timeFrame: Assessed from 0 to 72 hours post-dose, summary measure (see description) reported.
measure: Total IV Morphine-equivalent Dose of Rescue Opioids
timeFrame: 0-72 hrs. post dose (after surgery)
measure: Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score
timeFrame: 0 to 72 hours
measure: Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours
timeFrame: From PACU Discharge to 72 Hours post-treatment
measure: Time to First Opioid Rescue Medication Use After Discharge From the PACU
timeFrame: From PACU Discharge to 72 Hours post-treatment
measure: Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS)
timeFrame: From admission to discharge from PACU (Approximately 0 to 12 hours)
Other outcomes:
Locations:
city: Florence
country: United States
facility: Durect Study Site 04
state: Alabama
city: Sheffield
country: United States
facility: Durect Study Site 03
state: Alabama
city: Arcadia
country: United States
facility: DURECT Study Site 24
state: California
city: Fontana
country: United States
facility: Durect Study Site 15
state: California
city: Laguna Hills
country: United States
facility: Durect Study Site 02
state: California
city: Laguna Hills
country: United States
facility: Durect Study Site 18
state: California
city: Pensacola
country: United States
facility: Durect Study Site 22
state: Florida
city: Indianapolis
country: United States
facility: Durect Study Site 12
state: Indiana
city: Royal Oak
country: United States
facility: Durect Study Site 21
state: Michigan
city: Jackson
country: United States
facility: Durect Study Site 17
state: Mississippi
city: Las Vegas
country: United States
facility: Durect Study Site 16
state: Nevada
city: Las Vegas
country: United States
facility: Durect Study Site 20
state: Nevada
city: Stony Brook
country: United States
facility: Durect Study Site 05
state: New York
city: Durham
country: United States
facility: Durect Study Site 13
state: North Carolina
city: Cleveland
country: United States
facility: Durect Study Site 09
state: Ohio
city: Cleveland
country: United States
facility: Durect Study Site 11
state: Ohio
city: Cleveland
country: United States
facility: Durect Study Site 07
state: Ohio
city: Philadelphia
country: United States
facility: Durect Study Site 14
state: Pennsylvania
city: Houston
country: United States
facility: Durect Study Site 08
state: Texas
city: Houston
country: United States
facility: DURECT Study Site 01
state: Texas
city: Plano
country: United States
facility: Durect Study Site 23
state: Texas
Study officials:
affiliation: Durect
name: Dave Ellis, MD
role: STUDY_DIRECTOR
References: