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

NCT01866917 | Terminated Phase 1 Results DMC

• 1 other identifier: 12-11-397
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Transversis Abdominis Plane Block; obese; robotic surgery; laparoscopic surgery

Outcome Measures

Primary Outcomes (2)

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

  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

  0, 1, and 2 hours

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

  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

  4hrs, 8hrs, 12hrs, and 24hrs.

Study Arms (2)

TAP

EXPERIMENTAL

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

Drug: Ropivacaine 0.5% 20cc injectate bilaterally

Saline

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ropivacaine 0.5% 20cc injectate bilaterally DRUG

TAP

Placebo DRUG

Also known as: Saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Conversions, non-obese women

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Moses Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Pain; Obesity

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Limitations of this study include interim analysis with limited sample size, thus it may result in inadequate power. Early termination due to pharmacist refusal to dispense the experimental Rx (no AEs/SAEs recorded). Only an abstract was written.

Results Point of Contact

• Title: Ja Hyun Shin
• Organization: Montefiore Medical Center

JASHIN@montefiore.org

718-920-5157

Study Officials

• Ja Hyun Shin

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Locations

US (1)