Urogynecologic SurgeryNCT01971372
Post-Operative Pain Management With NSAIDS
An observational study of Urogynecologic Surgery, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Urogynecologic Surgery
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female gender
- Available for reliable follow up
- Able to complete study assessment
- Scheduled for surgery by FPMRS surgeon
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Urogynecologic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urogynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikio Nihira, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971372
- Sponsor's protocol ID
- 3411
- Status last verified
- Jun 2016
- First submitted
- 23 Oct 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Methods of NSAID Delivery for Postoperative Pain
- ClinicalTrials.gov ID
- NCT01971372
- Acronym / sponsor ID
- 3411
- Conditions
- Urogynecologic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Female gender
- Available for reliable follow up
- Able to complete study assessment
- Scheduled for surgery by FPMRS surgeon
Key exclusion criteria (8 listed)
- Age <18 years
- Known renal impairment
- Congestive heart failure
- Dementia or inability to follow instructions
- Allergy to NSAIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain scores
Time frame: Within 24 hours after surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikio Nihira, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urogynecologic Surgery, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.