Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women

NCT ID: NCT01866917

Last Updated: 2020-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAP

Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe

Group Type EXPERIMENTAL

Ropivacaine 0.5% 20cc injectate bilaterally

Intervention Type DRUG

Saline

Patients will receive Normal saline 20cc injectate from a study labeled syringe

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ropivacaine 0.5% 20cc injectate bilaterally

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Saline

Eligibility Criteria

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Inclusion Criteria

* BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures

Exclusion Criteria

* Conversions, non-obese women
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ja Hyun Shin

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Moses Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12-11-397

Identifier Type: -

Identifier Source: org_study_id

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