Clinical trial NCT02818894: Spinal Anesthesia in Total Hip Arthroplasty
Official title: Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Total Hip Arthroplasty
Keywords: Hip replacement
Total hip arthroplasty
Anterior total hip replacement
Transient neurological symptoms
Spinal anesthesia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips. Osteoarthritis will be defined as pain with weight-bearing at the hip articulation together with radiographic findings
* Indicated for total hip arthroplasty
* Agreement to undergo spinal anesthesia for surgery

Exclusion Criteria:

* Patient refusal to undergo spinal anesthesia
* Patients with a known history of lumbar or sacral spinal fusion.
* Patients with a known history of prostate, urological, or kidney surgery.
* Patients who need monitoring of urine output during surgery (including patients with confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery).
* Current infection at site of injection
* Women of child-bearing potential who are on Medicare (child-bearing potential will be determined prior to surgery per Anesthesia standard of care)
* Hypovolemia
* Indeterminate neurologic disease
* Allergy or hypersensitivity to the study medications
* Currently taking any anti-coagulation medications or coagulopathic
* Increased intracranial pressure
* Subject is unable to make his/her own decision regarding the informed consent
* Subject is unable to read/understand English

Primary outcomes:
measure: Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation
timeFrame: Day 1 (day of surgery) Post-Operation
measure: Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation
timeFrame: Day 1 (day of surgery) Post-Operation
measure: Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7
timeFrame: Post-Operative Day 7
measure: Transient Neurological Symptoms Score on Post-Operative Day 7
timeFrame: Post-Operative Day 7
measure: Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14
timeFrame: Post-Operative Day 14
measure: Transient Neurological Symptoms Score on Post-Operative Day 14
timeFrame: Post-Operative Day 14
Secondary outcomes:
measure: Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia
timeFrame: Day 1 (day of surgery) Post-Operation
measure: Time to Ambulation After Recovery From Spinal Anesthesia
timeFrame: Day 1 (day of surgery) Post-Operation
measure: Count of Participants With Hypotension
timeFrame: Day 1 (day of surgery) Post-Operation
measure: Number of Participants Discharged 0, 1, or 2 Days Following Surgery
timeFrame: Up to Post-Operative Day 2
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Orthopaedic and Spine Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Thomas Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References: