NCT01971372

Brief Summary

Specific Aim 1: To identify differences in pain perception and satisfaction with pain control in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (NSAIDS) postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. Specific Aim 2: To compare the differences in narcotic usage and medication side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

October 23, 2013

Last Update Submit

June 8, 2016

Conditions

Urogynecologic Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Three visual analog scores (VAS) will be obtained from the patient before noon on the first day after surgery. One scale to assess pain at rest, one scale to assess pain with ambulation, and one scale to assess satisfaction with pain control.

    Within 24 hours after surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited and consented through an IRB-approved process. Women and minorities are included in the research protocol. We will not exclude potential subjects from participating in this or any study solely on the basis of ethnic origin or socioeconomic status. There are no children involved in this study.

You may qualify if:

  • Female gender
  • Available for reliable follow up
  • Able to complete study assessment
  • Scheduled for surgery by FPMRS surgeon

You may not qualify if:

  • Age \<18 years
  • Known renal impairment
  • Congestive heart failure
  • Dementia or inability to follow instructions
  • Allergy to NSAIDS
  • Allergy to hydromorphone
  • History of gastrointestinal bleeding or ulceration
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

  • Mikio Nihira, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

US(1)