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OpenTrials
Completed

NCT Number: NCT02110719

Decreasing Narcotics in Advanced Pelvic Surgery

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.

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Key information

Conditions

Narcotic Use Constipation Nausea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hartford Hosptial

Hartford, Connecticut, 06102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celebrex

Drug

Gabapentin

Drug

IV acetaminophen

Drug

Oral acetaminophen

Drug

oral ibuprofen

Drug

Percocet

Drug

vicodin

Drug

Oxycodone

Drug

dilaudid

Drug

Dexamethasone

Drug

Zofran

Drug

Primary outcomes

  1. Narcotic use

    Time frame: 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 outcomes

  1. Pain

    Time frame: postoperative day #1 and postoperative week #1

    pain will be evaluated at the above listed time points using the validated brief pain inventory

  2. Nausea

    Time frame: intraoperatively, postoperatively

    Nausea will be evaluated based on the use of narcotics in the hospital

  3. Constipation

    Time frame: one week postoperatively

    constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study

Acronym: Pain

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 10, 2014
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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