NCT02061774

Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion

Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen:

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Texas Tech University Health Sciences Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Detailed description

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. The advantages of intravenous acetaminophen are well known in the literature and its opioid-sparing effects have been documented in multiple surgical studies. Multimodal regimens are now being advocated in the literature to decrease opioid use (8, 23). This is especially significant in spine surgery patients who often have chronic pain requiring long-term use of these habit-forming drugs as well as in patients who may not be able to tolerate opiods due to health status. To our knowledge there are no studies done in the U.S. on the opioid sparing and pain reducing effects of intravenous acetaminophen on patients undergoing elective minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. Investigating intravenous acetaminophen, particularly its pain reducing and opioid sparing effects, may give surgeons another medication for use in a multimodal approach to pain.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen	1 gram of intravenous Acetaminophen
DRUG	Placebo comparator	placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-01-11
• Completion: 2018-01-11
• First posted: 2014-02-13
• Last updated: 2020-05-06
• Results posted: 2020-04-24

Locations

1 site across 1 country: United States