A Single-dose, Open-Label Pilot Study to Assess the Technique for Administering LNP in Herniorrhaphy Surgery

This study is currently recruiting participants.
Verified September 2012 by PainReform LTD
Sponsor:
Information provided by (Responsible Party):
PainReform LTD
ClinicalTrials.gov Identifier:
NCT01681966
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The formulation is designed to slowly release the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the need for systemic analgesics is expected to be reduced and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.


Condition Intervention Phase
Open Inguinal Hernia Surgery
Drug: LNP- oily solution (Ropivacaine)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by PainReform LTD:

Primary Outcome Measures:
  • Evaluate the safety of LNP when administrated in a surgical setting [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    All AE's reported by the subjects will be recorded


Secondary Outcome Measures:
  • Evaluated the plasma PK profile of LNP [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Blood samples will betaken for evaluation of plasma ropivacaine levels


Other Outcome Measures:
  • Evaluate the duration of analgesia witnessed in the surgical setting [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Pain scales and questioners will be used to evaluate the pain intensity following the surgical procedure


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNP- oily solution
A new extended release oily solution formulation of ropivacaine
Drug: LNP- oily solution (Ropivacaine)
Other Name: Ropivacaine oily solution

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects between 18-55 years of age who are scheduled to undergo herniorrhaphy surgery;
  2. Subjects are within ±15% of ideal body weight/height (based on frame size) as given by the Metropolitan Life Insurance Tables;
  3. Subjects are ASA Category I or II and in normal physical health (other than the need for the surgical procedure) as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse;
  4. Subjects must agree to refrain from ingesting any analgesic medication for 2 days or 5 half-lives of the drug prior to the study period;; refrain from using caffeine and alcohol on surgery day and during the study period; and use only the analgesic medication provided by the study team during the study period;
  5. The subject is capable of reading, comprehending, and signing the informed consent form.

Exclusion Criteria:

  1. Patients who have surgical complications such as excessive blood loss;
  2. Subjects that are expected to use PCA to control the post-operative pain;
  3. Subjects with a history of melena or any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;
  4. Subjects with a history of any type of cancer;
  5. Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver, kidney, or thyroid conditions);
  6. Subjects with any history of alcohol or substance abuse;
  7. Subjects that currently have or have a history of uncontrolled hypertension;
  8. Subjects with a known hypersensitivity to any local anesthetic drug;
  9. Subjects with a hematocrit level below the normal range on the screening laboratory examination;
  10. Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
  11. Subjects with any condition or history felt by the Investigator to place the subject at increased risk;
  12. Consumption of food or drinks containing alcohol, grapefruit, caffeine, or xanthine (e.g., coffee, tea, caffeinated soft drinks, chocolate, etc.) on surgery day. Such restricted items include coffee, tea, Coke® Pepsi®, Mountain Dew®, chocolate, etc;
  13. Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
  14. Subjects who have used an investigational drug within 30 days prior to entering the study;
  15. Subjects who have donated blood within 3 months prior to the start of the study (including blood donation related to the surgical procedure);
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681966

Contacts
Contact: Michael Naveh, Dr. +972-9-9601914 mnaveh@painreform.com

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: David Zeltzer, Pro'f    +972-3-6973313    davidz@tasmc.health.gov.il   
Principal Investigator: David Zeltzer, Pro'f         
Sponsors and Collaborators
PainReform LTD
Investigators
Principal Investigator: David Zeltzer, Prof' Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: PainReform LTD
ClinicalTrials.gov Identifier: NCT01681966     History of Changes
Other Study ID Numbers: LNP-IL102
Study First Received: September 5, 2012
Last Updated: September 7, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014