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Postoperative Opioid Consumption After Urogyneocologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586219
Recruitment Status : Active, not recruiting
First Posted : July 13, 2018
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Kristen Buono, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Behavioral: Opioid-specific educational patient pamphlets Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Effect of Preoperative Patient Education on Postoperative Opioid Consumption, Storage, and Disposal After Urogynecologic Procedures
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
No Intervention: Control Arm
Standard preoperative and postoperative instructions will be provided to the study subjects
Experimental: Intervention Arm
Intervention: Study subjects will receive opioid-specific educational patient pamphlets in addition to standard preoperative and postoperative instructions
Behavioral: Opioid-specific educational patient pamphlets
See prior description




Primary Outcome Measures :
  1. 2 week postoperative opioid consumption [ Time Frame: 2 weeks after the surgery ]
    Mean number of opioid tablets consumed 2 weeks postoperatively


Secondary Outcome Measures :
  1. Modified Surgical Pain Score [ Time Frame: Between the preoperative assessment and 6 weeks after surgery ]
    To be collected at the preoperative assessment and 2 weeks and 6 weeks after surgery. This is a 4 question score that evaluates pain at rest, with normal activities, with strenuous activities, and quantifies bother or discomfort associated with the pain. A numerical answer for each question is selected from a 10 point scale ranging from 0 (no pain or bother) to 10 (maximum pain or bother). Higher scores are associated with worse outcomes.

  2. Preoperative Patient Survey answers [ Time Frame: 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. ]
    Investigator-initiated survey to assess for chronic pain conditions and general understanding of opioid disposal patterns

  3. Postoperative Patient Survey answers [ Time Frame: 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. ]
    Investigator-initiated survey assessing patient satisfaction with opioid prescription, storage and disposal patterns, that will be conducted at 2 weeks, 6 weeks, and 12 weeks after the surgery

  4. Additional opioid prescriptions [ Time Frame: 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. ]
    The electronic medical records at each site, as well as the California Department of Justice CURES 2.0 database will be evaluated 2 weeks, 6 weeks, 12 weeks, and 12 months after the surgery

  5. Intraoperative complications [ Time Frame: 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. ]
    Defined as the presence of packed red blood cell transfusion, bowel injury, bladder injury, ureteral injury, or conversion to laparotomy

  6. Postoperative complications [ Time Frame: The electronic medical record will be reviewed 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. ]
    Defined as either the presence of mesh exposure, wound infection, packed red blood cell transfusion, neuropathy, or urinary tract infection within 6 weeks postoperatively or return to the operating room for within 14 days post operatively

  7. Postoperative Oral Morphine Equivalents Prior to Discharge [ Time Frame: The electronic medical record will be reviewed 2 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. ]
    Total daily oral morphine equivalents prescribed in the hospital prior to discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586219


Locations
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United States, California
Kaiser Permanente Orange County - Anaheim
Anaheim, California, United States, 92806
Kaiser Permanente Orange County-Irvine Medical Center
Irvine, California, United States, 92618
University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Kaiser Permanente
Investigators
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Principal Investigator: Kristen Buono, MD University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Kristen Buono, University of California, Irvine:
Informed Consent Form  [PDF] June 4, 2018

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Responsible Party: Kristen Buono, Fellow, Female Pelvic Medicine and Reconstructive Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03586219    
Other Study ID Numbers: 2017-4003
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristen Buono, University of California, Irvine:
Surgery
Patient Education
Opioid
Medication Storage
Medication Disposal
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents