Pain Relief by Intra-Peritoneal Nebulization of Ropivacai... | NCT00927979

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

NCT00927979

Sponsor

Carmel Medical Center

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Gynecological Laparoscopy

Interventions

10 mLRopivacaine 1%
Water for injection
10 mL Ropivacaine 1%

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PSDR	Other Identifier	Gynecology Dept. Code

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 24, 2009

First Posted Date

Jun 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine	Experimental		Drug: 10 mLRopivacaine 1% Drug: 10 mL Ropivacaine 1%
Water for injection	Placebo Comparator		Drug: Water for injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
10 mLRopivacaine 1%	Drug	Intraperitoneal nebulization of 10 mL Ropivacaine 1%	Ropivacaine

Measure	Description	Time Frame
Visual Analog Score (VAS)		24 hours

Measure	Description	Time Frame
Use of Analgesics		24 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014867	Water
D007267	Injections

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided