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

Phase 1

Terminated

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Ropivacaine 0.5% 20cc injectate bilaterally

• Registration Number: NCT01866917
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2019-12-19
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-20
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

• Conversions, non-obese women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Patients will receive Normal saline 20cc injectate from a study labeled syringe
TAP	Ropivacaine 0.5% 20cc injectate bilaterally	Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe

Primary Outcome Measures

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

Trial Locations

Locations (1)

Moses Medical Center; 🇺🇸 Bronx, New York, United States