Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery

NCT02959476 | Completed Phase 3 FDA Drug

• 1 other identifier: 94006184
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 11

Brief Summary

This study evaluates a Ropivacaine 0.2% Pre-Filled Dispenser in the treatment of post-surgical pain in patients undergoing Cesarean delivery. Half of the patients will receive Ropivicaine and half will receive placebo.

Conditions

Pain, Postoperative

Keywords

Postoperative pain; Postsurgical pain

Outcome Measures

Primary Outcomes (1)

• Cumulative analgesic effect

  48 hours

Secondary Outcomes (4)

• Use of other analgesics

  48 hours

• Local safety and tolerability using descriptive statistics of the evaluation of physical exams, wound healing and treatment-emergent adverse events local to the surgical wound

  7 days

• Overall safety using descriptive statistics of the evaluation of physical exam, vital signs, clinical laboratory tests, and treatment-emergent adverse events

  7 days

• Analgesic effect at specified intervals

  48 hours

Study Arms (2)

Ropivacaine 0.2%

EXPERIMENTAL

Naropin® (ropivacaine HCl Injection, USP) bolus + Ropivacaine 0.2% Pre-Filled Dispenser infusion - "Ropivacaine Infusion treatment arm"

Drug: Ropivacaine

Placebo

PLACEBO COMPARATOR

Naropin® (ropivacaine HCl Injection, USP) bolus + placebo infusion (normal saline) - "Placebo treatment arm"

Drug: Placebos

Interventions

Ropivacaine DRUG

Anesthetic

Ropivacaine 0.2%

Placebos DRUG

Inactive comparator

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete the informed consent process as documented by a signed informed consent form (ICF).
• Be in generally good health and classified as either PS-1 or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
• Have a single birth pregnancy. Can be parous or nulliparous.
• Be scheduled for a Cesarean Delivery
• Subjects undergoing emergency Cesarean Delivery will not be eligible for participation in this study.
• In the event a subject signs the ICF (but has not been randomized), has a C section planned and then has an emergency C section delivery, this subject will be considered a screen failure.
• In the unlikely event a subject signs the ICF and is randomized into the study, has a C section planned and then has an emergency C section delivery, this subject will continue in the study as planned.
• Be willing to complete the pain assessments according to the protocol and return to clinic as scheduled, as needed.

You may not qualify if:

• Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
• Have a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator.
• Have a history of any medical condition or surgical procedure that would alter the absorption, distribution, metabolism, or excretion of ropivacaine.
• Have, in the opinion of the investigator, a clinically significant abnormality in their clinical laboratory values (urinalysis, hematology and chemistry) at screening.
• Have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to Day 1.
• Weigh greater than 100 kg (220 lbs).
• Have made a plasma donation within 7 days prior to Day -1.
• Have a known allergy or hypersensitivity to anesthetics (eg. Ropivacaine), acetaminophen, or non-steroidal anti inflammatory drugs (NSAIDs, eg, ibuprofen or naproxen, ketorolac).
• Not be able or willing to discontinue the prohibited medications listed below within the allotted time before surgery and throughout the duration of their participation in the study.
• monoamine oxidase inhibitors (MAOIs) within the past 30 days
• anticonvulsants, tricyclic antidepressants (TCAs), neuroleptics, serotonin-norepinephrine reuptake inhibitors (SNRIs), as well as selective serotonin reuptake inhibitors (SSRIs) (unless SSRIs have been prescribed for depression and/or anxiety and subjects have been on a stable dose for at least 30 days prior to the screening visit);
• Corticosteroids: Oral and injectable corticosteroids must be discontinued 3 months prior to surgery; nasal, inhaled and topical corticosteroids will be allowed;
• Use concurrent therapy that could interfere with the evaluation of efficacy or safety parameters in the opinion of the investigator (eg, any drugs, in the investigator's opinion, that may exert significant analgesic properties), except for rescue medications.
• Have a history of seizures or history of serious head injury.
• Must not be a member of a vulnerable population as defined by the Code of Federal Regulations Title 45, Part 46, Delivery 46.111(b), including but not limited to employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the Sponsor, or of the Clinical Research Organization.

Sponsors & Collaborators

• BioQ Pharma, Inc.: lead
• Premier Research: collaborator

Study Sites (11)

Clinical Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Shoals Medical Trials, Inc.

Sheffield, Alabama, 35660, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Vision Clinical Research

Wellington, Florida, 33414, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

MedPharmics, LLC

Biloxi, Mississippi, 39531, United States

Location

Duke University Medical Center

Durham, North Carolina, 27606, United States

Location

Compass Clinical Trial

Beaumont, Texas, 77702, United States

Location

Physician's Research Options, LLC- Corner Canyon OB/GYN

Draper, Utah, 84020, United States

Location

Health Sciences Center- University of Utah

Salt Lake City, Utah, 84112, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 9, 2016
• Study Start: March 13, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-04

Locations

US (11)