Decreasing Narcotics in Advanced Pelvic Surgery (Pain)

Hartford Hospital

Status and phase: Completed; Phase 4

Conditions: Nausea; Constipation; Pain; Narcotic Use

Treatments: Drug: oral ibuprofen; Drug: oral acetaminophen; Drug: IV acetaminophen; Drug: Dexamethasone; Drug: Gabapentin; Drug: Oxycodone; Drug: Celebrex; Drug: dilaudid; Drug: zofran; Drug: percocet; Drug: vicodin

Study type: Interventional

Funder types: Other

Identifiers

NCT02110719

REAG00414HU

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Standard

Active Comparator group

Description:

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

Treatment:

Drug: dilaudid

Drug: oral acetaminophen

Drug: oral ibuprofen

Drug: vicodin

Drug: percocet

Multimodal

Active Comparator group

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

Treatment:

Drug: Dexamethasone

Drug: dilaudid

Drug: oral acetaminophen

Drug: oral ibuprofen

Drug: IV acetaminophen

Drug: Gabapentin

Drug: zofran

Drug: Celebrex

Drug: Oxycodone