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Decreasing Narcotics in Advanced Pelvic Surgery (Pain)

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ClinicalTrials.gov Identifier: NCT02110719
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : June 2016

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110719


Locations
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United States, Connecticut
Hartford Hosptial
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
Investigators
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Principal Investigator: Krista Reagan, MD Hartford Hospital

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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT02110719     History of Changes
Other Study ID Numbers: REAG00414HU
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hartford Hospital:
narcotic use
pain
constipation
nausea

Additional relevant MeSH terms:
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Nausea
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Ibuprofen
Celecoxib
Ondansetron
Acetaminophen
Oxycodone
Gabapentin
Hydromorphone
BB 1101
Narcotics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic