Decreasing Narcotics in Advanced Pelvic Surgery (Pain)

Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Nausea; Constipation; Narcotic Use
• Intervention / Treatment: Drug: Gabapentin; Drug: Dexamethasone; Drug: Oxycodone; Drug: Celebrex; Drug: IV acetaminophen; Drug: oral ibuprofen; Drug: oral acetaminophen; Drug: percocet; Drug: vicodin; Drug: dilaudid; Drug: zofran

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 ibuprofen; Drug: oral acetaminophen; 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: Gabapentin; Drug: Dexamethasone; Drug: Oxycodone; Drug: Celebrex; Drug: IV acetaminophen; Drug: oral ibuprofen; Drug: oral acetaminophen; Drug: dilaudid; Drug: zofran

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Krista Reagan, MD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: pain; nausea; constipation; narcotic use
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Constipation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Cyclooxygenase 2 Inhibitors; Dexamethasone; Gabapentin; Celecoxib; Acetaminophen; Ibuprofen; Oxycodone; Hydromorphone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: REAG00414HU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO