Pain: Decreasing Narcotics in Advanced Pelvic Surgery

Sponsor

Hartford Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02110719

Collaborator

(none)

138

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Narcotic Use Pain Constipation Nausea	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	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard 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 Drug: oral ibuprofen Drug: percocet Drug: vicodin Drug: dilaudid
Active Comparator: 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	Drug: Celebrex Drug: Gabapentin Drug: IV acetaminophen Drug: oral acetaminophen Drug: oral ibuprofen Drug: Oxycodone Drug: dilaudid Drug: Dexamethasone Drug: zofran

Arm

Intervention/Treatment

Active Comparator: Standard

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

Drug: oral ibuprofen

Drug: percocet

Drug: vicodin

Drug: dilaudid

Active Comparator: 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

Drug: Celebrex

Drug: Gabapentin

Drug: IV acetaminophen

Drug: oral acetaminophen

Drug: oral ibuprofen

Drug: Oxycodone

Drug: dilaudid

Drug: Dexamethasone

Drug: zofran

Outcome Measures

Primary Outcome Measures

Narcotic use [intraoperative, immediate postoperative and 1 week postoperative]
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 [postoperative day #1 and postoperative week #1]
pain will be evaluated at the above listed time points using the validated brief pain inventory
Nausea [intraoperatively, postoperatively]
Nausea will be evaluated based on the use of narcotics in the hospital
Constipation [one week postoperatively]
constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale