Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy

Phase 3 Prospective, Randomized, Controlled and Double-blinded Second Trial on Pain Relief by Continuous Intra-peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia, During Gynecological Laparoscopic Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927979

Acronym

PSDR

Enrollment

Registered

2009-06-25

Start date

2009-06-30

Completion date

2010-10-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Laparoscopy

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 gynecologic laparoscopic surgery. This is a second steady with protocol of general anesthesia used of Remifentanil.

Detailed description

Outcome Measures : * VAS score * Use of analgesics during operation and postoperative period

Interventions

DRUG10 mLRopivacaine 1%

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

DRUGWater for injection

Intraperitoneal nebulization of 10 mL water for injection

DRUG10 mL Ropivacaine 1%

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Elective gynecological laparoscopic surgery including unilateral or bilateral salpingo-oophorectomy or ovarian cystectomy * Patient not participating in other medical study at present or during the last 30 days * Patient is capable of reading, understanding and signing on an informed consent * Age 18 years and above * ASA physical status grade 1-2

Exclusion criteria

* Allergy to ropivacaine or other local anesthetics or other medications listed in the protocol * Acute pelvic inflammatory disease * Coumadin or aspirin treatment * Significant arrythmias * Analgesic treatment for chronic pain * BMI\>35

Design outcomes

Primary

Measure	Time frame
Visual Analog Score (VAS)	24 hours

Secondary

Measure	Time frame
Use of Analgesics	24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026