Pain Clinical Trial
— PainOfficial title:
Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study
Verified date | August 2016 |
Source | Hartford Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | June 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hartford Hosptial | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Hartford Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Pain | pain will be evaluated at the above listed time points using the validated brief pain inventory | postoperative day #1 and postoperative week #1 | No |
Secondary | Nausea | Nausea will be evaluated based on the use of narcotics in the hospital | intraoperatively, postoperatively | No |
Secondary | Constipation | constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale | one week postoperatively | No |
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