Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 7:59 PM
Ignite Modification Date: 2025-12-24 @ 7:59 PM
NCT ID: NCT04990804
Brief Summary: Patients undergoing 1-3 level Anterior Cervical Discectomy and Fusion (ACDF) at the levels between C2 and T1 will be enrolled into this randomized prospective study. All patients enrolled in this study will undergo a trial of non-surgical treatment prior to the recommendation for surgery. After enrollment, patients will be randomized utilizing a block randomization strategy to one of two treatment groups - a standard opioid-containing postoperative pain regimen versus a non-opioid postoperative pain regimen. Postoperative outcomes will be assessed.
Detailed Description: Patients will be followed for 12 months and the following Specific Aims will be assessed: Aim 1: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to lower rates of new chronic opioid use when compared with postoperative pain regimens utilizing opioids. Aim 2: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF results in equivalent postoperative pain scores in the early postoperative period. Aim 3: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to equivalent clinical outcomes when compared with postoperative pain regimens utilizing opioids at 3 months and 12 months. Aim 4: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to fewer postoperative complications when compared with postoperative pain regimens utilizing opioids.
Study: NCT04990804
Study Brief:
Protocol Section: NCT04990804