Post-Operative Pain Management With NSAIDS

Comparing Methods of NSAID Delivery for Postoperative Pain

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.

Study Overview

• Status: Completed
• Conditions: Urogynecologic Surgery

Detailed Description

All patient will be informed that they may receive either ibuprofen or ketorolac and that the medication may be given (IV) or per os (PO). Patients were also informed that their pain may improve or worsen during the study, and that they could request additional pain medication (as a rescue medication) at any time.

After surgery, all patients will be placed initially on a patient controlled analgesia (PCA) of hydromorphone with standardized settings of allowing the patient to dispense 0.2 mg of medication every 6 minutes (lockout rate) and an hourly maximum of 2.0 mg/hour. A one-time nursing bolus of 0.4 mg will also be ordered. The PCA will be discontinued on the morning after surgery no later than 12:00 noon. The patient will then be started on PO pain medication, either hydrocodone/acetaminophen or oxycodone/acetaminophen.

Immediately after surgery, patients will then be assigned to one of three treatment arms with a computer-generated randomization schedule that is to be based on their order of enrollment. Patients were informed they could withdraw at any point. 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.

The medications will each be given every 8 hours in order to keep all medications on a similar doing regimen. This will allow the patients to receive a total of three doses of medication over 24 hours, regardless of which arm of the study they are randomized to.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Mikio Nihira, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 3411