Spinals in THA (Total Hip Arthroplasty)

Sponsor

Emory University (Other)

Overall Status

Terminated

CT.gov ID

NCT02818894

Collaborator

(none)

138

Enrollment

Locations

Arms

41.2

Actual Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Lidocaine Drug: Bupivacaine	Phase 3

Detailed Description

Participants will have their patient records examined prospectively and complete up to four telephone questionnaires after randomization to lidocaine or bupivacaine spinal anesthesia to see how they are feeling after their total hip arthroplasty (THA). Transient neurological symptoms, urinary retention, timing of full mobilization, incidence of hypotension, and length of hospital stay will be recorded for both methods of spinal anesthesia for comparison.

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 27, 2016

Actual Primary Completion Date :

Mar 5, 2020

Actual Study Completion Date :

Mar 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lidocaine prior to THA Participants receiving Total Hip Arthroplasty through anterior approach with Lidocaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.	Drug: Lidocaine Spinal anesthesia administered prior to participant's THA
Active Comparator: Bupivacaine prior to THA Participants receiving Total Hip Arthroplasty through anterior approach with Bupivacaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.	Drug: Bupivacaine Spinal anesthesia administered prior to participant's THA

Arm

Intervention/Treatment

Active Comparator: Lidocaine prior to THA

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

Drug: Lidocaine

Spinal anesthesia administered prior to participant's THA

Active Comparator: Bupivacaine prior to THA

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

Drug: Bupivacaine

Spinal anesthesia administered prior to participant's THA

Outcome Measures

Primary Outcome Measures

Transient Neurological Symptoms [1 Day Post-Operation to 3 Days Post-Operation]
Following a prepared questionnaire, the study team member will ask about symptoms of TNS and pain not associated with the operation area. The subject will be asked to specify the location of the symptoms and grade the complaints after a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort. Scores between the two study arms will indicate if there's a difference in TNS after surgery between lidocaine and bupivacaine spinal anesthesia in THA patients.
Transient Neurological Symptoms [3 Days Post-Operation to 7 Days Post-Operation]
Following a prepared questionnaire, the study team member will ask about symptoms of TNS and pain not associated with the operation area. The subject will be asked to specify the location of the symptoms and grade the complaints after a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort. Scores between the two study arms will indicate if there's a difference in TNS after surgery between lidocaine and bupivacaine spinal anesthesia in THA patients.
Transient Neurological Symptoms [7 Days Post-Operation to 14 Days Post-Operation]
Following a prepared questionnaire, the study team member will ask about symptoms of TNS and pain not associated with the operation area. The subject will be asked to specify the location of the symptoms and grade the complaints after a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort. Scores between the two study arms will indicate if there's a difference in TNS after surgery between lidocaine and bupivacaine spinal anesthesia in THA patients.

Secondary Outcome Measures

Time of First Voiding after recovery from spinal anesthesia [1 Day Post-Operation to 3 Days Post-Operation]
Urine retention will be captured through the use of an intermittent catheter or foley catheterization and data obtained through review of the inpatient records. Additionally, subjects will be asked for the time of their first voiding by a study team member. Average times between the two study arms will indicate if there's a difference in urinary retention after surgery between lidocaine and bupivacaine spinal anesthesia in THA patients.
Timing of ambulation after recovery from spinal anesthesia [1 Day Post-Operation to 3 Days Post-Operation]
Following a prepared questionnaire, the study team member will ask the participant about the time to full mobilization. Additional data regarding timing of ambulation during hospital stay will be obtained from the participant's inpatient medical chart. Average times between the two study arms will indicate if there's a difference in timing of ambulation after surgery between lidocaine and bupivacaine spinal anesthesia in THA patients.
Incidence of hypotension [1 Day Post-Operation to 3 Days Post-Operation]
Hypotension is defined as systolic blood pressure <90 mmHg Vitals are obtained by the study team member from reviewing the inpatient medical chart. Average systolic blood pressure readings between the two study arms will indicate if there's a difference in incidence of hypotension between lidocaine and bupivacaine spinal anesthesia in THA patients.
Length of hospital stay [1 Day Post-Operation to 14 Days Post-Operation]
Overall length of stay (in days) gathered from the participant's inpatient chart. Overall length of stay = discharge date - admission date Average length of stay between the two study arms,will indicate if there's a difference in length of hospital stay between lidocaine and bupivacaine spinal anesthesia in THA patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Orthopaedic and Spine Hospital	Atlanta	Georgia	United States	30329
2	The Emory Clinic	Atlanta	Georgia	United States	30329

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator: Thomas Bradbury, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas L Bradbury, MD, Associate Professor, Emory University

ClinicalTrials.gov Identifier:

NCT02818894

Other Study ID Numbers:

IRB00083867

First Posted:

Jun 30, 2016

Last Update Posted:

Jan 13, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Thomas L Bradbury, MD, Associate Professor, Emory University

THA, Hip Replacement, Spinal Anesthesia

Total hip arthroplasty

anterior total hip replacement

Additional relevant MeSH terms:

Osteoarthritis

Lidocaine

Bupivacaine

Study Results

No Results Posted as of Jan 13, 2022