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Clinical Trials/NCT01866917
NCT01866917
Terminated
Phase 1

Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures

Montefiore Medical Center1 site in 1 country35 target enrollmentApril 2013

Overview

Phase
Phase 1
Intervention
Ropivacaine 0.5% 20cc injectate bilaterally
Conditions
Pain
Sponsor
Montefiore Medical Center
Enrollment
35
Locations
1
Primary Endpoint
Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
April 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Conversions, non-obese women

Arms & Interventions

TAP

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

Intervention: Ropivacaine 0.5% 20cc injectate bilaterally

Saline

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

Intervention: Placebo

Outcomes

Primary Outcomes

Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

Time Frame: 0, 1, and 2 hours

Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable

Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

Time Frame: 4hrs, 8hrs, 12hrs, and 24hrs.

Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable

Study Sites (1)

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