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Intraperitoneal Atomization of Ropivacaine During Gynecologic Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01623635
Recruitment Status : Unknown
Verified February 2012 by University of Padova.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
University of Padova

Brief Summary:

Pain following laparoscopic surgery continues to be a clinically important problem with 80% or more patients requiring opioid analgesia post-operatively to control their pain. By reducing this surgical complication patients can experience less discomfort and be discharged from the recovery room more rapidly leading to reduced resource utilization and expense.

HYPOTHESIS: Post-operative pain after laparoscopic procedures could be treated by topical anesthetics sprayed directly into the abdomen (inside the abdominal cavity, on the nerve endings of the visceral peritoneal lining and diaphragm surface) via the surgical incision METHODS: Randomized controlled trial on use of topical anesthetic (namely 0.25% ropivacaine) delivered directly onto the target sites both at the beginning and the end of surgery in patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign pathology. The drug will be delivered using a CE approved delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).

GOAL: to assess the efficacy of intraperitoneal topical anesthesia in reducing postoperative pain, opioid requirements in patients undergoing laparoscopic gynecologic procedure for uterine or adnexal benign pathology


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Drug: placebo (normal saline) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraperitoneal Atomization of Ropivacaine During Gynecologic Laparoscopic Surgery: Impact on Pain, Opioid Use and Length of Recovery Room Stay
Study Start Date : February 2012
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Case - adnexal Drug: Ropivacaine

ADMINISTRATION OF STUDY DRUG All surgical port sites will be injected with 2 ml/each study drug prior to trocar insertion

Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes:

  • each subdiaphragmatic area 3.5 ml + 3.5ml
  • surgical dissection site 3 ml
  • diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining medication with be atomized again onto the same areas, using the same volumes.

At the end of the case - this process will be repeated with the remaining drug (no repeat port site injections).

Placebo Comparator: placebo - adnexal Drug: placebo (normal saline)

ADMINSTRATION OF PLACEBO All surgical port sites will be injected with 2 ml/each placebo prior to trocar insertion

Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the placebo will be delivered as an atomized spray in the following volumes:

  • each subdiaphragmatic area 3.5 ml + 3.5ml
  • surgical dissection site 3 ml
  • diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining placebo with be atomized again onto the same areas, using the same volumes.

At the end of the case - this process will be repeated with the remaining placebo (no repeat port site injections).

Experimental: case - uterine Drug: Ropivacaine

ADMINISTRATION OF STUDY DRUG All surgical port sites will be injected with 2 ml/each study drug prior to trocar insertion

Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes:

  • each subdiaphragmatic area 3.5 ml + 3.5ml
  • surgical dissection site 3 ml
  • diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining medication with be atomized again onto the same areas, using the same volumes.

At the end of the case - this process will be repeated with the remaining drug (no repeat port site injections).

Placebo Comparator: placebo - uterine Drug: placebo (normal saline)

ADMINSTRATION OF PLACEBO All surgical port sites will be injected with 2 ml/each placebo prior to trocar insertion

Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the placebo will be delivered as an atomized spray in the following volumes:

  • each subdiaphragmatic area 3.5 ml + 3.5ml
  • surgical dissection site 3 ml
  • diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining placebo with be atomized again onto the same areas, using the same volumes.

At the end of the case - this process will be repeated with the remaining placebo (no repeat port site injections).




Primary Outcome Measures :
  1. Post-operative pain intensity [ Time Frame: at 6h post-operatively ]
    NRS score. (NRS; 0 = no pain and 10 = worse pain possible)at 6 hours post-operatively


Secondary Outcome Measures :
  1. Total post-operative opioid analgesic requirements [ Time Frame: in the first 48 hours post-operatively or until discharge ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective laparoscopic surgical intervention for benign uterine or adnexal conditions

Exclusion Criteria:

  • Less than 18 year old
  • Pregnancy
  • Prisoners
  • Allergic/contraindications to topical anesthetics (Amides specifically)
  • Allergic/contraindications to Opioids as a class
  • Allergic/contraindications to acetaminophen
  • Allergic/contraindications to Propofol
  • Allergic/contraindications to NSAIDS
  • Currently or within the last 30 days been prescribed an opiate medication
  • History of drugs or alcohol abuse
  • Chronic pain syndrome
  • Suspected gynecologic malignancy
  • Poor comprehension of written and spoken Italian for informed consent purpose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623635


Contacts
Contact: Carlo Saccardi, M.D., Ph.D. +39.049.8218524 carlo.saccardi@unipd.it
Contact: Massimo MIcaglio, M.D. +39.049.8213454 m.micaglio@libero.it

Locations
Italy
Azienda Ospedaliera-Università Padova Recruiting
Padova, Italy, 35128
Contact: Carlo Saccardi, M.D., Ph.D.    +39.049.8218524    carlo.saccardi@unipd.it   
Contact: Massimo Micaglio, M.D.    +39.049.8213454    m.micaglio@libero.it   
Principal Investigator: Carlo Saccardi, M.D., Ph.D.         
Principal Investigator: Massimo Micaglio, M.D.         
Principal Investigator: Matteo Parotto, M.D., Ph.D.         
Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Carlo Saccardi, M.D., Ph.D. University of Padova
Principal Investigator: Massimo Micaglio, M.D. Azienda Ospedaliera Padova
Principal Investigator: Matteo Parotto, M.D., Ph.D. Università di Padova

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01623635     History of Changes
Other Study ID Numbers: 2011-004203-20
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents