Spinal Anesthesia in Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02818894
• Other study ID #: IRB00083867
• Status: Terminated
• Phase: Phase 4
• Start date: September 27, 2016
• Est. completion date: March 5, 2020

Study information

• Verified date: August 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 135
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Drug:
• Lidocaine
Spinal anesthesia administered prior to participant's THA
• Bupivacaine
Spinal anesthesia administered prior to participant's THA

Locations

Country	Name	City	State
United States	Emory University Orthopaedic and Spine Hospital	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Thomas L Bradbury

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 (day of surgery) Post-Operation
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.	Day 1 (day of surgery) Post-Operation
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.	Post-Operative Day 7
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.	Post-Operative Day 7
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.	Post-Operative Day 14
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.	Post-Operative Day 14
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.	Day 1 (day of surgery) Post-Operation
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.	Day 1 (day of surgery) Post-Operation
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.	Day 1 (day of surgery) Post-Operation
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.	Up to Post-Operative Day 2