Pelvic Organ ProlapseNCT03586219
Postoperative Opioid Consumption After Urogyneocologic Surgery
A study testing Opioid-specific educational patient pamphlets in people with Pelvic Organ Prolapse, run by University of California, Irvine at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Opioid-specific educational patient pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Dec 2017to 28 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente Orange County - Anaheim
Anaheim, California, 92806
Kaiser Permanente Orange County-Irvine Medical Center
Irvine, California, 92618
University of California Irvine Medical Center
Orange, California, 92868
About this study
Official title: 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.
Read the 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
- Being tested
- Opioid-specific educational patient pamphlets
- Keywords
- Surgery, Patient Education, Opioid, Medication Storage, Medication Disposal
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-specific educational patient pamphletsBehavioural
See prior description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Opioid-specific educational patient pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 week postoperative opioid consumption
Mean number of opioid tablets consumed 2 weeks postoperatively
Measured: 2 weeks after the surgery
Secondary outcomes (7)
Modified Surgical Pain Score
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.
Measured: Between the preoperative assessment and 6 weeks after surgery
Preoperative Patient Survey answers
Investigator-initiated survey to assess for chronic pain conditions and general understanding of opioid disposal patterns
Measured: 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
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
Measured: 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
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
Measured: 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
Defined as the presence of packed red blood cell transfusion, bowel injury, bladder injury, ureteral injury, or conversion to laparotomy
Measured: 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.
Postoperative complications
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
Measured: 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.
Postoperative Oral Morphine Equivalents Prior to Discharge
Total daily oral morphine equivalents prescribed in the hospital prior to discharge
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start29 Dec 2017
- Primary completion28 Nov 2020
- Study completion28 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Kristen Buono, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586219
- Sponsor's protocol ID
- 2017-4003
- Status last verified
- Apr 2021
- First submitted
- 12 Mar 2018
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33620897
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Preoperative Patient Education on Postoperative Opioid Consumption, Storage, and Disposal After Urogynecologic Procedures
- ClinicalTrials.gov ID
- NCT03586219
- Acronym / sponsor ID
- 2017-4003
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Surgery, Patient Education, Opioid, Medication Storage, Medication Disposal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 13 Jul 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Standard preoperative and postoperative instructions will be provided to the study subjects |
| Intervention Arm | Experimental | Behavioral: Opioid-specific educational patient pamphletsIntervention: Study subjects will receive opioid-specific educational patient pamphlets in addition to standard preoperative and postoperative instructions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid-specific educational patient pamphletsSee prior description | Behavioural | Intervention Arm |
Primary outcome
2 week postoperative opioid consumption
Time frame: 2 weeks after the surgery
Mean number of opioid tablets consumed 2 weeks postoperatively
7 secondary outcomes
Modified Surgical Pain Score
Time frame: Between the preoperative assessment and 6 weeks after surgery
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.
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.
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.
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.
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.
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.
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 15 Apr 2021.
- Derived from this study: PubMed 33620897Buono 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.
- Individual participant dataSharing planned: No
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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.
Kristen Buono, MD principal investigator
University of California, Irvine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid-specific educational patient pamphlets in people with Pelvic Organ Prolapse, run by University of California, Irvine at 3 sites 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 4 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
2 week postoperative opioid consumption (time frame: 2 weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03586219, which also lists 1 linked publication.
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 15 Apr 2021.