NCT00433316

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.

Trial Health

87
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 Feb 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

February 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 20, 2008

Status Verified

February 1, 2007

Enrollment Period

8 months

First QC Date

February 8, 2007

Last Update Submit

June 19, 2008

Conditions

Laparoscopic Surgical Procedures

Keywords

ropivacainelaparoscopyintraperitonealnebulizationpainlocal analgesicgynecology

Outcome Measures

Primary Outcomes (1)

  • VAS score

    early post-operative

Study Arms (2)

study

EXPERIMENTAL

Receiving 10ml of 1% ropivacaine

Drug: ropivacaine

Control

PLACEBO COMPARATOR

Receiving 10ml of saline

Device: Aeroneb Pro Nezulizer, Aerogen, Ireland

Interventions

ropivacaineDRUG

1% ropivacaine

Also known as: Narop
study
Aeroneb Pro Nezulizer, Aerogen, IrelandDEVICE

Aeroneb Pro Nezulizer, Aerogen, Ireland

Control

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Carmel Medical Center Ambulatory Gynecoendoscopic Unit

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Yuval Kaufman, MD

    Carmel Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

  • Reuven Pizov, Prof.

    Carmel Medical Center, Haifa, Israel

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 9, 2007

Study Start

February 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 20, 2008

Record last verified: 2007-02

Locations

IL(1)