Postoperative Opioid Consumption After Urogyneocologic Surgery



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 99
Updated:7/15/2018
Start Date:December 21, 2017
End Date:December 31, 2020
Contact:Kristen Buono, MD
Email:kbuono@uci.edu
Phone:714-456-6807

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Evaluating the Effect of Preoperative Patient Education on Postoperative Opioid Consumption, Storage, and Disposal After Urogynecologic Procedures

The purpose of this randomized controlled trial is to evaluate whether preoperative opioid
education will reduce postoperative opioid consumption after urogynecologic surgeries.
Additionally, the effect of the opioid education on opioid storage and disposal patterns will
be evaluated. The pattern of opioid consumption 2 and 6 weeks after surgery will be compared
between patients in the study arms. The rates of prescription refills 12 weeks and 12 months
after the surgery will be compared between patients in the study arms.

The study concept would be introduced to the patients at the prior to or during the
preoperative visit. If the patient agrees to participation during any of these encounters,
written consent and HIPPA authorization will be obtained and the patient would be randomized
to the intervention or control arm using a computerized randomization scheme on REDCap. The
randomization will be stratified by hospital system the surgery was performed within (UC
Irvine Medical Center versus Kaiser Permanente Southern California). If the patient is
randomized to the intervention arm, the first opioid informational pamphlet will be provided
and reviewed with the patient in addition to standard preoperative instructions. If the
patient is randomized to the control arm, standard preoperative instructions will be
provided. Patients within both arms of the study will receive standardized postoperative
medication prescriptions prior to the surgery. Patients within both arms of the study will
complete the modified surgical pain score and preoperative opioid education study survey
prior to surgery.

After the surgery is completed, the primary surgeon will decide whether to admit the patient
to the hospital and which postoperative analgesics will be administered within the hospital
prior to discharge for subjects in both study arms. The patient will follow up for standard
postoperative clinic visits at 2 weeks and 6 weeks postoperatively. One to two days prior to
the 2 week postoperative visit, the patients will be contacted via telephone to remind them
to bring their opioid prescription bottles to the clinic visit.

Between the surgery date and the 2 week postoperative visit, the electronic medical records
will be reviewed to evaluate the length of the surgery, intraoperative complications, the
postoperative date of discharge, the postoperative date of removal of the transurethral foley
catheter, the total daily morphine equivalents that the patient was prescribed prior to
discharge from the hospital, and the presence of opioid prescriptions 30 days prior to the
surgery. Additionally, the CURES 2.0 Database will be queried to evaluate for opioid
prescriptions 30 days prior to the surgery.

During the 2 week postoperative visit, the remaining opioid tablets will be counted and
recorded by a co-investigator. The patient will complete the modified surgical pain score and
postoperative opioid education study survey. The electronic medical record system and CURES
2.0 Database will be queried to evaluate for additional opioid prescriptions since the time
of surgery. Patients randomized to the intervention arm will receive the second opioid
informational pamphlet, which will be reviewed by a co-investigator.

During the 6 week the patient will complete the modified surgical pain score and
postoperative opioid education study survey. The electronic medical record system and CURES
2.0 Database will be queried to evaluate for additional opioid prescriptions since the time
of surgery. The patients' electronic medical records will be reviewed after the 6 week
postoperative visit to evaluate for postoperative complications.

Twelve week after the surgery, the electronic medical record system and CURES 2.0 Database
will be queried to evaluate for additional opioid prescriptions since the time of surgery.

If a patient fails to follow up for a postoperative visit, at least two attempts will be made
to contact the patient via telephone to collect opioid pill counts and have the patient
verbally complete the modified surgical pain score and postoperative opioid education study
survey. Initial statistical analysis will be performed after the 12 week postoperative review
of the electronic medical records and CURES 2.0 Database have been completed.

Twelve months after the surgery, the electronic medical record system and CURES 2.0 Database
will be queried to evaluate for additional opioid prescriptions since the time of surgery.
Additional statistical analysis will be performed after the 12 month opioid refill
prescriptions have been evaluated.

While this is a multi-site trial involving subjects from UC Irvine Medical Center, Kaiser
Permanente Orange County - Irvine, and Kaiser Permanente Orange County - Anaheim, only
de-identified data will be uploaded into the REDCap data management system. The lead
investigator will maintain a separate key containing patient health information for subjects
from both sites, which will be utilized to evaluate for additional opioid prescriptions 12
months after the surgery. Co-investigators from both study sites will not have access to
identifiable data from subjects that were not recruited from their particular study site.

Inclusion Criteria:

- Female

- Age 18-99 years old

- English speaking

- Evaluated by a provider within the Urogynecology division at UC Irvine Medical Center,
Kaiser Permanente Orange County - Irvine Medical Center, or Kaiser Permanente Orange
County - Anaheim Medical Center, and consented for either a uterosacral ligament
suspension, sacrospinous ligament fixation, minimally-invasive colpopexy (either
laparoscopic or robotic-assisted laparoscopic), colporrhaphy, or colpocleisis

Exclusion Criteria:

- Non English-speaking

- Cognitive deficits that would prevent the patient from completing the study
questionnaires

- Cancellation of the surgery

- Combined case with another surgical service (i.e. colorectal surgery)
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Anaheim, California 92806
Phone: 714-456-6807
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Irvine, California 92618
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101 The City Drive South
Orange, California 92868
714-456-7890
Phone: 714-456-6807
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