Pain Relief by Intra-Peritoneal Ropivacaine During Gyneco... | NCT00433316

Studies
Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

NCT00433316

Sponsor

Carmel Medical Center

Status

Completed

Last Update Posted

Jun 20, 2008Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Laparoscopic Surgical Procedures

Interventions

ropivacaine
Aeroneb Pro Nezulizer, Aerogen, Ireland

Countries

Israel

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
HT 3758

Status Module

Record Verification Date

Feb 2007

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

Feb 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Feb 8, 2007

First Submission Date that Met QC Criteria

Feb 8, 2007

First Posted Date

Feb 9, 2007Estimated

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 19, 2008

Last Update Posted Date

Jun 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 gynecological laparoscopic surgery.

Detailed Description

Not provided

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
study	Experimental	Receiving 10ml of 1% ropivacaine	Drug: ropivacaine
Control	Placebo Comparator	Receiving 10ml of saline	Device: Aeroneb Pro Nezulizer, Aerogen, Ireland

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ropivacaine	Drug	1% ropivacaine	study	Narop

Measure	Description	Time Frame
VAS score		early post-operative

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuval Kaufman, MD	Carmel Medical Center, Haifa, Israel	Principal Investigator
Reuven Pizov, Prof.	Carmel Medical Center, Haifa, Israel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Carmel Medical Center Ambulatory Gynecoendoscopic Unit		Haifa		34362	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided