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Post Operative PainPhase 3PERSISTNCT02574520

Trial of Extended Release Bupivacaine for Pain Relief After Surgery

A Phase 3 study testing SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2) and Bupivacaine HCl in people with Post Operative Pain, run by Durect at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Operative Pain
What is being tested?
SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2) and Bupivacaine HCl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
21 sitesUnited States
Study dates
Nov 2015to Aug 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • DURECT Study Site 24

    Arcadia, California, 91007

  • Durect Study Site 09

    Cleveland, Ohio, 44106

  • Durect Study Site 11

    Cleveland, Ohio, 44111

  • Durect Study Site 07

    Cleveland, Ohio, 44195

  • Durect Study Site 13

    Durham, North Carolina, 27710

  • Durect Study Site 04

    Florence, Alabama, 35360

  • Durect Study Site 15

    Fontana, California, 92335

  • Durect Study Site 08

    Houston, Texas, 77004

  • DURECT Study Site 01

    Houston, Texas, 77043

  • Durect Study Site 12

    Indianapolis, Indiana, 46202

  • Durect Study Site 17

    Jackson, Mississippi, 39202

  • Durect Study Site 02

    Laguna Hills, California, 92653

  • Durect Study Site 18

    Laguna Hills, California, 92653

  • Durect Study Site 16

    Las Vegas, Nevada, 89104

  • Durect Study Site 20

    Las Vegas, Nevada, 89109

  • Durect Study Site 22

    Pensacola, Florida, 32503

  • Durect Study Site 14

    Philadelphia, Pennsylvania, 19107

  • Durect Study Site 23

    Plano, Texas, 75093

  • Durect Study Site 21

    Royal Oak, Michigan, 48073

  • Durect Study Site 03

    Sheffield, Alabama, 35660

  • Durect Study Site 05

    Stony Brook, New York, 11794

Other trials in United States

About this study

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)

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).

Being tested
SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2), Saline Placebo, Bupivacaine HCl
Keywords
Post-operative pain, non-opioid analgesic, opioid reduction, laparoscopic cholecystectomy, laparoscopic surgery, bupivacaine, extended release, locally acting analgesic
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SABER-Bupivacaine (Part 1)Drug

    Also called POSIMIR® bupivacaine solution

    5 ml once at end of surgery

  • SABER-Bupivacaine (Part 2)Drug

    Also called POSIMIR® bupivacaine solution

    5 ml once at end of surgery

  • Saline PlaceboDrug

    Also called placebo

    5 ml once at end of surgery

  • Bupivacaine HClDrug

    0.5%, 15 ml, once at end of surgery

Study groups in NCT02574520
Study groupRoleWhat they receive
Part 1Placebo comparatorSABER-Bupivacaine and Saline Placebo
Receives: Drug: SABER-Bupivacaine (Part 1); Drug: Saline Placebo
Part 2Active comparatorSABER-Bupivacaine and Bupivacaine HCl
Receives: Drug: SABER-Bupivacaine (Part 2); Drug: Bupivacaine HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessed from 0 to 48 hours post-dose, summary measure (see description) reported.

Secondary outcomes (6)

  1. 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.

    Measured: Assessed from 0 to 72 hours post-dose, summary measure (see description) reported.

  2. Total IV Morphine-equivalent Dose of Rescue Opioids

    IV morphine-equivalent dose

    Measured: 0-72 hrs. post dose (after surgery)

  3. 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.

    Measured: 0 to 72 hours

  4. Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours

    Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl

    Measured: From PACU Discharge to 72 Hours post-treatment

  5. Time to First Opioid Rescue Medication Use After Discharge From the PACU

    Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl

    Measured: From PACU Discharge to 72 Hours post-treatment

  6. 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.

    Measured: From admission to discharge from PACU (Approximately 0 to 12 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJun 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02574520
Sponsor's protocol ID
C803-028
Acronym
PERSIST
Status last verified
Jun 2021
First submitted
9 Oct 2015
Last updated
13 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2) and Bupivacaine HCl in people with Post Operative Pain, run by Durect at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity on Movement From 0-48 Hours Post-Treatment (time frame: Assessed from 0 to 48 hours post-dose, summary measure (see description) reported.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02574520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.

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