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Decreasing Narcotics in Advanced Pelvic Surgery (Pain)

Primary Purpose

Narcotic Use, Pain, Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Celebrex
Gabapentin
IV acetaminophen
oral acetaminophen
oral ibuprofen
percocet
vicodin
Oxycodone
dilaudid
Dexamethasone
zofran
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcotic Use focused on measuring narcotic use, pain, constipation, nausea

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hartford Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard

Multimodal

Arm Description

Patients will be given the following: no preoperative medications intraoperative medications per anesthesia postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
pain will be evaluated at the above listed time points using the validated brief pain inventory
Nausea
Nausea will be evaluated based on the use of narcotics in the hospital
Constipation
constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale

Full Information

First Posted
April 7, 2014
Last Updated
August 15, 2016
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02110719
Brief Title
Decreasing Narcotics in Advanced Pelvic Surgery
Acronym
Pain
Official Title
Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcotic Use, Pain, Constipation, Nausea
Keywords
narcotic use, pain, constipation, nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Patients will be given the following: no preoperative medications intraoperative medications per anesthesia postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed
Arm Title
Multimodal
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Celebrex
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Type
Drug
Intervention Name(s)
IV acetaminophen
Intervention Type
Drug
Intervention Name(s)
oral acetaminophen
Intervention Type
Drug
Intervention Name(s)
oral ibuprofen
Intervention Type
Drug
Intervention Name(s)
percocet
Intervention Type
Drug
Intervention Name(s)
vicodin
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Type
Drug
Intervention Name(s)
dilaudid
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
zofran
Primary Outcome Measure Information:
Title
Narcotic use
Description
Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point
Time Frame
intraoperative, immediate postoperative and 1 week postoperative
Secondary Outcome Measure Information:
Title
Pain
Description
pain will be evaluated at the above listed time points using the validated brief pain inventory
Time Frame
postoperative day #1 and postoperative week #1
Title
Nausea
Description
Nausea will be evaluated based on the use of narcotics in the hospital
Time Frame
intraoperatively, postoperatively
Title
Constipation
Description
constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale
Time Frame
one week postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Reagan, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hosptial
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Decreasing Narcotics in Advanced Pelvic Surgery

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