Trial of Extended Release Bupivacaine for Pain Relief After Surgery

NCT ID: NCT02574520

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 399 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-08-31

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).

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1

SABER-Bupivacaine and Saline Placebo

Group Type: PLACEBO_COMPARATOR

SABER-Bupivacaine (Part 1)

Intervention Type: DRUG

5 ml once at end of surgery

Saline Placebo

Intervention Type: DRUG

5 ml once at end of surgery

Part 2

SABER-Bupivacaine and Bupivacaine HCl

Group Type: ACTIVE_COMPARATOR

SABER-Bupivacaine (Part 2)

Intervention Type: DRUG

5 ml once at end of surgery

Bupivacaine HCl

Intervention Type: DRUG

0.5%, 15 ml, once at end of surgery

Interventions

SABER-Bupivacaine (Part 1)

5 ml once at end of surgery

Intervention Type: DRUG

SABER-Bupivacaine (Part 2)

5 ml once at end of surgery

Intervention Type: DRUG

Saline Placebo

5 ml once at end of surgery

Intervention Type: DRUG

Bupivacaine HCl

0.5%, 15 ml, once at end of surgery

Intervention Type: DRUG

Other Intervention Names

POSIMIR® bupivacaine solution; POSIMIR® bupivacaine solution; placebo

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Durect

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dave Ellis, MD

Role: STUDY_DIRECTOR

Durect

Locations

Durect Study Site 04

Florence, Alabama, United States

Durect Study Site 03

Sheffield, Alabama, United States

DURECT Study Site 24

Arcadia, California, United States

Durect Study Site 15

Fontana, California, United States

Durect Study Site 02

Laguna Hills, California, United States

Durect Study Site 18

Laguna Hills, California, United States

Durect Study Site 22

Pensacola, Florida, United States

Durect Study Site 12

Indianapolis, Indiana, United States

Durect Study Site 21

Royal Oak, Michigan, United States

Durect Study Site 17

Jackson, Mississippi, United States

Durect Study Site 16

Las Vegas, Nevada, United States

Durect Study Site 20

Las Vegas, Nevada, United States

Durect Study Site 05

Stony Brook, New York, United States

Durect Study Site 13

Durham, North Carolina, United States

Durect Study Site 09

Cleveland, Ohio, United States

Durect Study Site 11

Cleveland, Ohio, United States

Durect Study Site 07

Cleveland, Ohio, United States

Durect Study Site 14

Philadelphia, Pennsylvania, United States

Durect Study Site 08

Houston, Texas, United States

DURECT Study Site 01

Houston, Texas, United States

Durect Study Site 23

Plano, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C803-028

Identifier Type: -

Identifier Source: org_study_id