Laparoscopic Surgical Procedures
Conditions
Keywords
ropivacaine, laparoscopy, intraperitoneal, nebulization, pain, local analgesic, gynecology
Brief summary
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.
Interventions
DRUGropivacaine
1% ropivacaine
DEVICEAeroneb Pro Nezulizer, Aerogen, Ireland
Aeroneb Pro Nezulizer, Aerogen, Ireland
Sponsors
Carmel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score | early post-operative |
Countries
Israel
Outcome results
None listed