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Completed

NCT Number: NCT00433316

Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.

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Key information

Conditions

Laparoscopic Surgical Procedures Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

the Carmel Medical Center Ambulatory Gynecoendoscopic Unit

Haifa, 34362, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
  • The patient is not participating in other medical study at present or in the last 30 days.
  • The patient signed on an informed consent.
  • Age 18 years and above.
  • ASA (American Society of Anesthesiologists) physical status grade 1- 2.

Exclusion criteria

  • Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
  • The patient is participating in other medical experiment at present or in the last 30 days.
  • Acute Pelvic Inflammatory Disease.
  • Coumadin or Aspirin treatment.
  • ASA physical status grade 3-4.
  • Age < 18 years.
  • Significant arrythmias
  • Analgesic treatment for chronic pain

Treatment and study plan

Ropivacaine

Drug

1% ropivacaine

Other names: Narop

Aeroneb Pro Nezulizer, Aerogen, Ireland

Device

Aeroneb Pro Nezulizer, Aerogen, Ireland

Primary outcomes

  1. VAS score

    Time frame: early post-operative

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 9, 2007
Registry last updated
Jun 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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