Clinical trial NCT01971372: Post-Operative Pain Management With NSAIDS
Official title: Comparing Methods of NSAID Delivery for Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urogynecologic Surgery
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores
timeFrame: Within 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Mikio Nihira, MD
role: PRINCIPAL_INVESTIGATOR
References: