Total Hip Arthroplasty
Conditions
Keywords
Hip replacement, Total hip arthroplasty, Anterior total hip replacement, Transient neurological symptoms, Spinal anesthesia
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.
Interventions
DRUGLidocaine
Spinal anesthesia administered prior to participant's THA
DRUGBupivacaine
Spinal anesthesia administered prior to participant's THA
Sponsors
Thomas L Bradbury
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Spinal Anesthesia Participants scheduled for total hip arthroplasty (THA) who were randomized to receive lidocaine spinal anesthesia. | 67 |
| Bupivacaine Spinal Anesthesia Participants scheduled for total hip arthroplasty (THA) who were randomized to receive bupivacaine spinal anesthesia. | 68 |
| Total | 135 |
Baseline characteristics
| Characteristic | Bupivacaine Spinal Anesthesia | Total | Lidocaine Spinal Anesthesia |
|---|---|---|---|
| Age, Continuous | 61.22 years STANDARD_DEVIATION 10.98 | 61.13 years STANDARD_DEVIATION 11.04 | 61.08 years STANDARD_DEVIATION 11.056 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 68 participants | 135 participants | 67 participants |
| Sex: Female, Male Female | 29 Participants | 66 Participants | 37 Participants |
| Sex: Female, Male Male | 39 Participants | 69 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 68 |
| other Total, other adverse events | 0 / 67 | 0 / 68 |
| serious Total, serious adverse events | 0 / 67 | 0 / 68 |
Outcome results
Primary
Number of Participants With Transient Neurological Symptoms on 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.
Time frame: Post-Operative Day 14
Population: This analysis includes participants who completed the Neurological Symptoms Checklist. Thirteen participants in the Bupivacaine group participated in the Post-Operative Day 14 follow-up phone call but only 12 completed the TNS assessment. The remaining missing participants were lost to follow up, were not called for the Post-Operative Day 14 assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lidocaine Spinal Anesthesia | Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14 | 9 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14 | 3 Participants |
Primary
Number of Participants With Transient Neurological Symptoms on 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.
Time frame: Post-Operative Day 7
Population: This analysis includes participants who completed the Neurological Symptoms Checklist. One participant in the lidocaine group participated in the Post-Operative Day 7 follow-up phone call but did not complete the Neurological Symptoms Checklist. The remaining missing participants were lost to follow up, were not called for this follow-up assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lidocaine Spinal Anesthesia | Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7 | 3 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7 | 4 Participants |
Primary
Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 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.
Time frame: Day 1 (day of surgery) Post-Operation
Population: This analysis includes participants who completed the Neurological Symptoms Checklist. Two participants were assessed for other outcomes post-operatively on day of surgery but TNS was not evaluated. Sixteen participants were not assessed post-operatively on day of surgery for any outcomes, or their records were lost. Details about some study visits are no longer available and the exact reasons for the missing data cannot be determined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lidocaine Spinal Anesthesia | Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation | 3 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation | 1 Participants |
Primary
Post-Operative Transient Neurological Symptoms Score on Day 1 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.
Time frame: Day 1 (day of surgery) Post-Operation
Population: This analysis includes participants reporting any type of TNS following surgery, on the day of surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Spinal Anesthesia | Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation | 2 score on a scale | Standard Deviation 1 |
| Bupivacaine Spinal Anesthesia | Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation | 4 score on a scale | Standard Deviation 0 |
Primary
Transient Neurological Symptoms Score on 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.
Time frame: Post-Operative Day 14
Population: This analysis includes participants reporting any type of TNS following surgery on Post-Operative Day 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Spinal Anesthesia | Transient Neurological Symptoms Score on Post-Operative Day 14 | 2.56 score on a scale | Standard Deviation 1.88 |
| Bupivacaine Spinal Anesthesia | Transient Neurological Symptoms Score on Post-Operative Day 14 | 5.67 score on a scale | Standard Deviation 3.06 |
Primary
Transient Neurological Symptoms Score on 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.
Time frame: Post-Operative Day 7
Population: This analysis includes participants reporting any type of TNS during the Post-Operative Day 7 follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Spinal Anesthesia | Transient Neurological Symptoms Score on Post-Operative Day 7 | 2.33 score on a scale | Standard Deviation 2.52 |
| Bupivacaine Spinal Anesthesia | Transient Neurological Symptoms Score on Post-Operative Day 7 | 5.75 score on a scale | Standard Deviation 4.19 |
Secondary
Count of Participants With Hypotension
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.
Time frame: Day 1 (day of surgery) Post-Operation
Population: This analysis includes participants with post-operative blood pressure data recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lidocaine Spinal Anesthesia | Count of Participants With Hypotension | 2 Participants |
| Bupivacaine Spinal Anesthesia | Count of Participants With Hypotension | 1 Participants |
Secondary
Number of Participants Discharged 0, 1, or 2 Days Following Surgery
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.
Time frame: Up to Post-Operative Day 2
Population: This analysis includes participants with discharge data collected from medical records. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lidocaine Spinal Anesthesia | Number of Participants Discharged 0, 1, or 2 Days Following Surgery | Day of surgery | 35 Participants |
| Lidocaine Spinal Anesthesia | Number of Participants Discharged 0, 1, or 2 Days Following Surgery | Post-operative Day 1 | 10 Participants |
| Lidocaine Spinal Anesthesia | Number of Participants Discharged 0, 1, or 2 Days Following Surgery | Post-operative Day 2 | 4 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants Discharged 0, 1, or 2 Days Following Surgery | Day of surgery | 44 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants Discharged 0, 1, or 2 Days Following Surgery | Post-operative Day 1 | 6 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants Discharged 0, 1, or 2 Days Following Surgery | Post-operative Day 2 | 1 Participants |
Secondary
Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia
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 frame: Day 1 (day of surgery) Post-Operation
Population: This analysis includes participants who had data regarding urinary voiding recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lidocaine Spinal Anesthesia | Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia | 47 Participants |
| Bupivacaine Spinal Anesthesia | Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia | 47 Participants |
Secondary
Time to Ambulation After Recovery From Spinal Anesthesia
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.
Time frame: Day 1 (day of surgery) Post-Operation
Population: This analysis includes participants who had the time when they were fully ambulatory recorded. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Spinal Anesthesia | Time to Ambulation After Recovery From Spinal Anesthesia | 279.3 minutes | Standard Deviation 273 |
| Bupivacaine Spinal Anesthesia | Time to Ambulation After Recovery From Spinal Anesthesia | 242.0 minutes | Standard Deviation 91.23 |