Postoperative Opioid Consumption After Urogyneocologic Surgery

NCT03586219 | Completed

• 1 other identifier: 2017-4003
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

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.

Conditions

Pelvic Organ Prolapse

Keywords

Surgery; Patient Education; Opioid; Medication Storage; Medication Disposal

Outcome Measures

Primary Outcomes (1)

• 2 week postoperative opioid consumption

  Mean number of opioid tablets consumed 2 weeks postoperatively

  2 weeks after the surgery

Secondary Outcomes (7)

• Modified Surgical Pain Score

  Between the preoperative assessment and 6 weeks after surgery

• Preoperative Patient Survey answers

  To be collected within 30 days prior to surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.

• Postoperative Patient Survey answers

  Conducted two times 2 weeks and 6 weeks after surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.

• Additional opioid prescriptions

  To be performed three times between 2 weeks to 12 months after the surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.

• Intraoperative complications

  These will be evaluated within the first 6 weeks after surgery. This data point will be included in the initial analysis that will be performed after the last enrolled patient has completed the 12 week postoperative chart review.

Study Arms (2)

Control Arm

NO INTERVENTION

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

Intervention Arm

EXPERIMENTAL

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

Behavioral: Opioid-specific educational patient pamphlets

Interventions

Opioid-specific educational patient pamphlets BEHAVIORAL

See prior description

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Female patients who are undergoing either reconstructive or obliterative surgeries for the indication of pelvic organ prolapse. Patients who identify as female but do not have the predisposing condition of pelvic organ prolapse will not be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead
• Kaiser Permanente: collaborator

Study Sites (3)

Kaiser Permanente Orange County - Anaheim

Anaheim, California, 92806, United States

Location

Kaiser Permanente Orange County-Irvine Medical Center

Irvine, California, 92618, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

• 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.

  PMID: 33620897 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristen Buono, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, non-blinded, controlled trial that will be performed at two sites. Study subjects will be randomized to either the control arm (standard perioperative instructions) or intervention arm (standard perioperative instructions with additional perioperative opioid-specific education) using a randomization program in a 1:1 ratio.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: July 13, 2018
• Study Start: December 29, 2017
• Primary Completion: November 28, 2020
• Study Completion: November 28, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)