NCT00927979

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

June 24, 2009

Last Update Submit

June 26, 2011

Conditions

Gynecological Laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Score (VAS)

    24 hours

Secondary Outcomes (1)

  • Use of Analgesics

    24 hours

Study Arms (2)

Ropivacaine

EXPERIMENTAL
Drug: 10 mLRopivacaine 1%Drug: 10 mL Ropivacaine 1%

Water for injection

PLACEBO COMPARATOR
Drug: Water for injection

Interventions

10 mLRopivacaine 1%DRUG

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Ropivacaine
Water for injectionDRUG

Intraperitoneal nebulization of 10 mL water for injection

Water for injection
10 mL Ropivacaine 1%DRUG

Intraperitoneal nebulization of 10 mL Ropivacaine 1%

Ropivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

WaterInjections

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

June 28, 2011

Record last verified: 2011-06