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Decreasing Narcotics in Advanced Pelvic Surgery

Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02110719
Acronym
Pain
Enrollment
138
Registered
2014-04-10
Start date
2014-03-31
Completion date
2016-06-30
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcotic Use, Pain, Constipation, Nausea

Keywords

narcotic use, pain, constipation, nausea

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.

Interventions

DRUGCelebrex
DRUGGabapentin
DRUGIV acetaminophen
DRUGOxycodone
DRUGDexamethasone
DRUGzofran

Sponsors

Hartford Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Narcotic useintraoperative, immediate postoperative and 1 week postoperativeNarcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point

Secondary

MeasureTime frameDescription
Painpostoperative day #1 and postoperative week #1pain will be evaluated at the above listed time points using the validated brief pain inventory
Nauseaintraoperatively, postoperativelyNausea will be evaluated based on the use of narcotics in the hospital
Constipationone week postoperativelyconstipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026