Decreasing Narcotics in Advanced Pelvic Surgery

NCT02110719 | Completed Phase 4

• 1 other identifier: REAG00414HU
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcotic Use; Pain; Constipation; Nausea

Keywords

narcotic use; pain; constipation; nausea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain

  postoperative day #1 and postoperative week #1

• Nausea

  intraoperatively, postoperatively

• Constipation

  one week postoperatively

Study Arms (2)

Standard

ACTIVE COMPARATOR

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

Multimodal

ACTIVE COMPARATOR

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

Interventions

Celebrex DRUG

Multimodal

Gabapentin DRUG

Multimodal

IV acetaminophen DRUG

Multimodal

oral acetaminophen DRUG

Multimodal; Standard

oral ibuprofen DRUG

Multimodal; Standard

percocet DRUG

Standard

vicodin DRUG

Standard

Oxycodone DRUG

Multimodal

dilaudid DRUG

Multimodal; Standard

Dexamethasone DRUG

Multimodal

zofran DRUG

Multimodal

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hosptial

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Pain; Constipation; Nausea

Interventions

Celecoxib; Gabapentin; Acetaminophen; Ibuprofen; oxycodone-acetaminophen; acetaminophen, hydrocodone drug combination; Oxycodone; Hydromorphone; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Aniline Compounds; Phenylpropionates; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Krista Reagan, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)