Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-01 @ 12:18 AM
Study NCT ID:
NCT02818894
Status:
TERMINATED
Last Update Posted:
2022-09-23
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spinal Anesthesia in Total Hip Arthroplasty
Sponsor:
Thomas L Bradbury
Organization:
Study Overview
Official Title:
Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to pressing matters related to the COVID-19 pandemic - staff shortages and changes of personnel, data gaps due to the pandemic, participants not being able to continue follow-up visits, and ongoing enrollment issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a total hip arthroplasty (THA). The objective of this study is to compare the two spinal anesthesia treatments in regards to transient neurological symptoms (TNS).
Detailed Description:
Most surgeons would agree total hip arthroplasty (THA) is one of the most successful surgical interventions. However, when it comes to the type of anesthesia to improve THA outcomes, surgeons do not agree. General anesthesia has been shown to be associated with increases in adverse events, increased operating room times and increased length of stay. Therefore, more surgeons are turning to spinal anesthesia for better pain control, decreased need for narcotics resulting in less nausea, sooner recovery of bowel function, and faster participation in physical therapy. All of these factors can lead to a sooner discharge from the hospital, which would lead to significant cost savings.
Transient neurological symptoms (TNS) are a concern of using spinal anesthesia and have been shown to occur up to 16-40% of the time with lidocaine. Symptoms of TNS have been described as pain, dysesthesia, or both that occur in the legs or buttocks and urinary retention after recovery from spinal anesthesia. Intensity of pain varies but can be quite severe. Symptoms can appear in a few hours, for up to 24 hours after surgery.
Lidocaine is the most widely used anesthetic due to its rapid onset, intense nerve blockade, and short duration of action. The risk of developing TNS after spinal anesthesia with lidocaine has been shown to be higher when compared to other anesthetics. However, it is unknown whether there are differences between patients who undergo spinal anesthesia with lidocaine versus bupivacaine in THA. This knowledge is important because it has been shown that bupivacaine spinal anesthesia is more effective than lidocaine with minimal adverse effects. A large randomized, prospective study is needed to prove the difference between the two types of anesthesia.
The primary objective of this study is to compare TNS among people who receive one of two spinal anesthesia treatments, lidocaine or bupivacaine. The study will be conducted on individuals who are indicated for THA and have agreed to have spinal anesthesia during their surgery. All patients will be randomized by a computer program and will receive either lidocaine or bupivacaine spinal anesthesia prior to their THA. In addition to TNS, other outcomes include urinary retention, hypotension, ambulation and length of hospital stay.
Transient neurological symptoms (TNS) are a concern of using spinal anesthesia and have been shown to occur up to 16-40% of the time with lidocaine. Symptoms of TNS have been described as pain, dysesthesia, or both that occur in the legs or buttocks and urinary retention after recovery from spinal anesthesia. Intensity of pain varies but can be quite severe. Symptoms can appear in a few hours, for up to 24 hours after surgery.
Lidocaine is the most widely used anesthetic due to its rapid onset, intense nerve blockade, and short duration of action. The risk of developing TNS after spinal anesthesia with lidocaine has been shown to be higher when compared to other anesthetics. However, it is unknown whether there are differences between patients who undergo spinal anesthesia with lidocaine versus bupivacaine in THA. This knowledge is important because it has been shown that bupivacaine spinal anesthesia is more effective than lidocaine with minimal adverse effects. A large randomized, prospective study is needed to prove the difference between the two types of anesthesia.
The primary objective of this study is to compare TNS among people who receive one of two spinal anesthesia treatments, lidocaine or bupivacaine. The study will be conducted on individuals who are indicated for THA and have agreed to have spinal anesthesia during their surgery. All patients will be randomized by a computer program and will receive either lidocaine or bupivacaine spinal anesthesia prior to their THA. In addition to TNS, other outcomes include urinary retention, hypotension, ambulation and length of hospital stay.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: