Decreasing Narcotics in Advanced Pelvic Surgery

Study Overview
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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.

Official Title
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Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study

Conditions
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Narcotic Use, Pain, Constipation, Nausea

Intervention / Treatment
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* Drug: Celebrex
* Drug: Gabapentin
* Drug: IV acetaminophen
* Drug: oral acetaminophen
* Drug: oral ibuprofen
* Drug: percocet
* Drug: vicodin
* Drug: Oxycodone
* Drug: dilaudid
* Drug: Dexamethasone
* Drug: zofran


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Patients will be given the following: no preoperative medications intraoperative medications per anesthesia postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed | Drug: oral acetaminophen<br> <br> Drug: oral ibuprofen<br> <br> Drug: percocet<br> <br> Drug: vicodin<br> <br> Drug: dilaudid<br> <br> |
| Active Comparator: Multimodal<br>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 | Drug: Celebrex<br> <br> Drug: Gabapentin<br> <br> Drug: IV acetaminophen<br> <br> Drug: oral acetaminophen<br> <br> Drug: oral ibuprofen<br> <br> Drug: Oxycodone<br> <br> Drug: dilaudid<br> <br> Drug: Dexamethasone<br> <br> Drug: zofran<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic use | Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point | intraoperative, immediate postoperative and 1 week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain will be evaluated at the above listed time points using the validated brief pain inventory | postoperative day #1 and postoperative week #1 | 
| Nausea | Nausea will be evaluated based on the use of narcotics in the hospital | intraoperatively, postoperatively | 
| Constipation | constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale | one week postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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narcotic use, pain, constipation, nausea