A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery

NCT03319277 | Completed Results

• 1 other identifier: 17-1012
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to determine the effect of decreased post-operative prescriptions of opiate medications after urogynecologic surgery.

Conditions

Postoperative Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Number of Patients Reporting Adequate Satisfaction

  Patient satisfaction was easured by the way they answered the following question: "Overall, how satisfied are you with your pain medication at home since your surgery?" Their answers were recorded via a rated scale with five options: "Very Satisfied", "Somewhat Satisfied", "Neutral", "Somewhat Satisfied", and "Very Unsatisfied" which goes from most favorable to least favorable, respectively. Patients who answered either "Very Satisfied" or "Somewhat Satisfied" were defined a priori to have adequate satisfaction.

  6-weeks after surgery

Secondary Outcomes (2)

• Number of Opiate Tablets Used by Patients

  6-weeks after surgery

• Number of Patients Willing to Destroy Excess Remaining Opioid Tablets

  6-weeks after surgery

Study Arms (2)

Routine opiate prescription

ACTIVE COMPARATOR

This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.

Other: Routine opiate prescription

Decreased opiate prescription

EXPERIMENTAL

This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.

Other: Decreased opiate prescription

Interventions

Decreased opiate prescription OTHER

The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.

Decreased opiate prescription

Routine opiate prescription OTHER

The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.

Routine opiate prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years or older
• Women scheduled to undergo minimally invasive surgery within the urogynecology division at Cleveland Clinic with a plan to stay one night in the hospital afterwards for a benign indication which includes:
• Vaginal hysterectomies with prolapse repair
• Sacrospinous ligament fixations
• Hysteropexy
• Sacrocolpopexy
• Women able to provide consent for research participation and to sign an informed consent

You may not qualify if:

• Women with chronic pain or chronic pain syndrome
• Women undergoing concurrent bowel surgery
• Women with pre-operative chronic opiate use
• Inability to comprehend written and/or spoken English
• Inability to provide informed consent
• Inability to take oxycodone
• Inability to take acetaminophen due to allergy or liver disease
• Women will be excluded if they undergo an unplanned laparotomy
• Pain catastrophization score

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Emily RW Davidson, M.D.
• Organization: Cleveland Clinic

dr.emily.rose@gmail.com

812-272-2380

Study Officials

• Emily RW Davidson, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 24, 2017
• Study Start: October 13, 2017
• Primary Completion: April 30, 2019
• Study Completion: June 25, 2019
• Last Updated: October 31, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)