Clinical trial NCT02959476: Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery
Official title: A Double Blind, Multi-center, Randomized, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Ropivacaine 0.2% Pre-Filled Dispenser for the Treatment of Postsurgical Pain in Patients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Postoperative pain
Postsurgical pain
Lead sponsor: BioQ Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Health Decisions
First posted: 2016-11-09
Enrollment: 132
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Have previously participated in a clinical trial using ropivacaine.
* Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study. Institutionalized subjects will not be eligible for participation.

Primary outcomes:
measure: Cumulative analgesic effect
timeFrame: 48 hours
Secondary outcomes:
measure: Use of other analgesics
timeFrame: 48 hours
measure: 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
timeFrame: 7 days
measure: Overall safety using descriptive statistics of the evaluation of physical exam, vital signs, clinical laboratory tests, and treatment-emergent adverse events
timeFrame: 7 days
measure: Analgesic effect at specified intervals
timeFrame: 48 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Associates, Inc.
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Trials, Inc.
state: Alabama
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Wellington
country: United States
facility: Vision Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Biloxi
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Beaumont
country: United States
facility: Compass Clinical Trial
state: Texas
city: Draper
country: United States
facility: Physician's Research Options, LLC- Corner Canyon OB/GYN
state: Utah
city: Salt Lake City
country: United States
facility: Health Sciences Center- University of Utah
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: