Alvimopan and Ileus in PSF

The Washington University

Status: Completed

Conditions: Ileus; Spinal Fusion

Treatments: Drug: Alvimopan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02218190

201401126

Details and patient eligibility

About

The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.

Full description

Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control.

We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis

Exclusion criteria

• pregnant women
• ischemic heart disease
• chronic liver or renal disease
• prior bowel resection
• presence of colostomy or ileostomy
• gastroparesis
• complete bowel obstruction
• inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Alvimopan

Experimental group

Description:

Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.

Treatment:

Drug: Alvimopan

Placebo - Sugar Pill

Placebo Comparator group

Description:

Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven

Treatment:

Drug: Placebo