Spinal Anesthesia in Total Hip Arthroplasty

NCT02818894 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00083867
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

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).

Conditions

Total Hip Arthroplasty

Keywords

Hip replacement; Total hip arthroplasty; Anterior total hip replacement; Transient neurological symptoms; Spinal anesthesia

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia

  Day 1 (day of surgery) Post-Operation

• Time to Ambulation After Recovery From Spinal Anesthesia

  Day 1 (day of surgery) Post-Operation

• Count of Participants With Hypotension

  Day 1 (day of surgery) Post-Operation

• Number of Participants Discharged 0, 1, or 2 Days Following Surgery

  Up to Post-Operative Day 2

Study Arms (2)

Lidocaine prior to THA

ACTIVE COMPARATOR

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.

Drug: Lidocaine

Bupivacaine prior to THA

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Interventions

Lidocaine DRUG

Spinal anesthesia administered prior to participant's THA

Lidocaine prior to THA

Bupivacaine DRUG

Spinal anesthesia administered prior to participant's THA

Bupivacaine prior to THA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas L Bradbury: lead

Study Sites (2)

Emory University Orthopaedic and Spine Hospital

Atlanta, Georgia, 30329, United States

Location

The Emory Clinic

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Interventions

Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The study was terminated due to extended suspension of the study related to personnel issues and pandemic-related issues. Missing data due to lost study records limited the number of available data points.

Results Point of Contact

• Title: Thomas L. Bradbury, MD
• Organization: Emory University

tombradburymd@gmail.com

404-759-3912

Study Officials

• Thomas Bradbury, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: September 27, 2016
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: September 23, 2022
• Results First Posted: September 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)