Decreasing Narcotics in Advanced Pelvic Surgery

Pain Clinical Trial

— Pain  

Official title:

Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110719
• Other study ID #: REAG00414HU
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2014
• Last updated: August 15, 2016
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Narcotic Use
• Nausea
• Pain

Intervention

Drug:
• Celebrex

• Gabapentin

• IV acetaminophen

• oral acetaminophen

• oral ibuprofen

• percocet

• vicodin

• Oxycodone

• dilaudid

• Dexamethasone

• zofran

Locations

Country	Name	City	State
United States	Hartford Hosptial	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

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