Spinal Anesthesia in Total Hip Arthroplasty

NCT ID: NCT02818894

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2020-03-05

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Lidocaine prior to THA

Participants scheduled for Total Hip Arthroplasty through anterior approach with Lidocaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Spinal anesthesia administered prior to participant's THA

Bupivacaine prior to THA

Participants scheduled for Total Hip Arthroplasty through anterior approach with Bupivacaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Spinal anesthesia administered prior to participant's THA

Interventions

Lidocaine

Spinal anesthesia administered prior to participant's THA

Intervention Type: DRUG

Bupivacaine

Spinal anesthesia administered prior to participant's THA

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas L Bradbury

OTHER

Sponsor Role: lead

Responsible Party

Thomas L Bradbury

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas Bradbury, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Orthopaedic and Spine Hospital

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00083867

Identifier Type: -

Identifier Source: org_study_id