Decreasing Narcotics in Advanced Pelvic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-06-30

Brief Summary

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In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.

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Detailed Description

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Conditions

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Narcotic Use Pain Constipation Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

Patients will be given the following:

* no preoperative medications
* intraoperative medications per anesthesia
* postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed

Group Type ACTIVE_COMPARATOR

oral acetaminophen

Intervention Type DRUG

oral ibuprofen

Intervention Type DRUG

percocet

Intervention Type DRUG

vicodin

Intervention Type DRUG

dilaudid

Intervention Type DRUG

Multimodal

Patients in the multimodal arm will receive the following:

* preoperative celebrex and gabapentin
* intraoperative IV acetaminophen, dexamethasone, zofran
* postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
* patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics

Group Type ACTIVE_COMPARATOR

Celebrex

Intervention Type DRUG

Gabapentin

Intervention Type DRUG

IV acetaminophen

Intervention Type DRUG

oral acetaminophen

Intervention Type DRUG

oral ibuprofen

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

dilaudid

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

zofran

Intervention Type DRUG

Interventions

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Celebrex

Intervention Type DRUG

Gabapentin

Intervention Type DRUG

IV acetaminophen

Intervention Type DRUG

oral acetaminophen

Intervention Type DRUG

oral ibuprofen

Intervention Type DRUG

percocet

Intervention Type DRUG

vicodin

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

dilaudid

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

zofran

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women \>/= 18 years old
* undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department

Exclusion Criteria

* males
* \<18 years old
* women unwilling or unable to consent
* same-day-discharge surgery
* history of chronic pain for which they use medications
* current or active history of narcotic abuse
* sleep apnea
* liver or kidney dysfunction
* sulfa allergy

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes