Spinal Anesthesia in Total Hip Arthroplasty
- Registration Number
- NCT02818894
- Lead Sponsor
- Thomas L Bradbury
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 135
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine prior to THA Bupivacaine 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. Lidocaine prior to THA Lidocaine 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation Day 1 (day of surgery) Post-Operation Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation Day 1 (day of surgery) Post-Operation Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7 Post-Operative Day 7 Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Transient Neurological Symptoms Score on Post-Operative Day 7 Post-Operative Day 7 Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14 Post-Operative Day 14 Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Transient Neurological Symptoms Score on Post-Operative Day 14 Post-Operative Day 14 Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
- Secondary Outcome Measures
Name Time Method Number of Participants Discharged 0, 1, or 2 Days Following Surgery Up to Post-Operative Day 2 Hospital length of stay was obtained from inpatient charts. Length of stay was determined using the hospital admission dates and discharge dates, and was then categorized as being discharged the same day as the surgery, the day after surgery, or two days after surgery.
Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia Day 1 (day of surgery) Post-Operation Urine retention after recovery from spinal anesthesia was assessed as the count of participants voiding without complications. Data were obtained through review of the inpatient records.
Time to Ambulation After Recovery From Spinal Anesthesia Day 1 (day of surgery) Post-Operation Time to ambulation after recovery from spinal anesthesia is assessed in minutes. Information about time to full ambulation was obtained by asking participants or from inpatient medical charts.
Count of Participants With Hypotension Day 1 (day of surgery) Post-Operation The number of participants experiencing hypotension, defined as systolic blood pressure of \<90 mmHg, is presented here. Blood pressure information was obtained from reviewing the inpatient medical charts.
Trial Locations
- Locations (2)
Emory University Orthopaedic and Spine Hospital
🇺🇸Atlanta, Georgia, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States