CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
Intravenous Infusion group +1 moredrug
Likely dose
Intravenous Infusion group 1,000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04562610
NCT04562610Phase 3Completed
CompareCT.gov

A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications

University of California, Davis·interventional·Posted Sep 24, 2020·Updated Aug 21, 2025

In Brief

A Phase 3 clinical trial evaluating Intravenous Infusion group and All oral administration group for Lumbar Surgery. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This study aims to determine the impact and effect of enhanced recovery after surgery (ERAS) principles in the recovery and rehabilitation of patients following elective orthopaedic spine surgery with a specific emphasis on oral versus intravenous preoperative medication administration and the resultant cost differences.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Surgery
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 24, 2020
Enrollment StartNov 18, 2020
Primary CompletionOct 9, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.8 years ago

Interventions

Intravenous Infusion groupdrug

The intravenous infusion group will receive two medications via the intravenous infusion route. These medications are Ofirmev ( acetaminophen ) 1,000mg and tranexamic acid 2,000 mg , an antifibrinolytic drug. In addition to these drugs, study subjects will receive Celecoxib 200mg by mouth and Gabapentin 600 mg by mouth prior to operation.

All oral administration groupdrug

Subjects in the oral administration group will receive the following pre-emptive analgesic drugs, acetaminophen 1,000mg, Celecoxib 200mg and gabapentin 600mg via the oral route prior to operation. In addition they will receive the antifibrinolytic drug, tranexamic acid 2,000mg via an oral route as well prior to operation.