Postoperative Opioid Consumption After Urogyneocologic Surgery

NCT ID: NCT03586219

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-29
• Study Completion Date: 2020-11-28

Brief Summary

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.

Detailed Description

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Arm

Standard preoperative and postoperative instructions will be provided to the study subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Intervention: Study subjects will receive opioid-specific educational patient pamphlets in addition to standard preoperative and postoperative instructions

Group Type: EXPERIMENTAL

Opioid-specific educational patient pamphlets

Intervention Type: BEHAVIORAL

See prior description

Interventions

Opioid-specific educational patient pamphlets

See prior description

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen Buono, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Kaiser Permanente Orange County - Anaheim

Anaheim, California, United States

Kaiser Permanente Orange County-Irvine Medical Center

Irvine, California, United States

University of California Irvine Medical Center

Orange, California, United States

Countries

United States

References

Buono K, Whitcomb E, Guaderrama N, Lee E, Ihara J, Sudol N, Lane F, Lee J, Heliker BD, Brueseke T. A Randomized Controlled Trial Assessing the Impact of Opioid-Specific Patient Counseling on Opioid Consumption and Disposal After Reconstructive Pelvic Surgery. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):151-158. doi: 10.1097/SPV.0000000000001009.

Reference Type: DERIVED

PMID: 33620897 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-4003

Identifier Type: -

Identifier Source: org_study_id