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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT06291727
Brief Summary:
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
Detailed Description:
The purpose of this study is to evaluate the two different spinal anesthesia agents, mepivacaine and bupivacaine, and determine whether there are significant differences in their effects on readiness for same day discharge following a total knee arthroplasty.
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted via telephone or RedCap at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
In this double-blind (patients and assessors) study, the patients will be randomly assigned 1:1 to receive one of the following: mepivacaine 1.5% (4.5ml, 67.5mg) or 2% (3.4ml, 67.5mg), (depending on availability from pharmacy) or hyperbaric bupivacaine 0.75% (1.4ml, 10.5mg) from the spinal kit. Randomization will be computer-generated in RedCap. These doses are the currently the standard doses used for our total knee arthroplasty patients. Patients with a height of 74 inches or greater or with body mass index of 35kg/m2 or greater will be given an extra 0.5ml of local anesthetic. The intraoperative anesthesia team will not be blinded to the group assignment, but patients, surgeons, and assessors are blinded. All patients will receive the standard preoperative multimodal analgesia, consisting of celecoxib 400mg po and acetaminophen 1gm po. Research staff will unblind the study investigators immediately if requested for any potential safety concerns.
Study:
NCT06291727
Study Brief:
Protocol Section:
NCT06291727