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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01866917
Recruitment Status : Unknown
Verified May 2013 by Ja hyun Shin, Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Ja hyun Shin, Montefiore Medical Center

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

Condition or disease Intervention/treatment Phase
Pain Drug: Ropivacaine 0.5% 20cc injectate bilaterally Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014

Arm Intervention/treatment
Experimental: TAP
Ropivicaine 0.5% 20cc injectate bilaterally
Drug: Ropivacaine 0.5% 20cc injectate bilaterally
Placebo Comparator: Saline
Normal saline 20cc injectate bilaterally
Drug: Ropivacaine 0.5% 20cc injectate bilaterally



Primary Outcome Measures :
  1. Pain [ Time Frame: First 24 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Conversions, non-obese women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866917


Contacts
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Contact: Ja Hyun Shin, MD 7189208383 jashin@montefiore.org

Locations
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United States, New York
Moses Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Ja Hyun Shin, MD    718-920-8382      
Sponsors and Collaborators
Montefiore Medical Center
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Responsible Party: Ja hyun Shin, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01866917    
Other Study ID Numbers: 12-11-397
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013
Keywords provided by Ja hyun Shin, Montefiore Medical Center:
Transversis Abdominis Plane Block
obese
robotic surgery
laparoscopic surgery
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents