Phase 4
N=159
3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty
Osteoarthritis, Hip
Bottom Line
View on ClinicalTrials.gov: NCT03948386 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Percentage Ambulating Early After Spinal Anesthesia — 9; 20; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- isobaric bupivacaine (Drug); hyperbaric bupivacaine (Drug); isobaric mepivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Ambulating Early After Spinal Anesthesia |
9; 20; 35 | — |
| SECONDARY Return of Motor Function of the Thigh and Lower Leg |
148; 123; 109 | — |
| SECONDARY Number of Patients With Dizziness Events |
11; 7; 9 | — |
| SECONDARY Number of Patients With Urinary Retention Events |
6; 8; 5 | — |
| SECONDARY Number of Patients With Transient Neurological Symptoms (TNS) |
2; 6; 5 | — |
| SECONDARY Hospital Stay |
26; 26; 22 | — |
Summary
Spinal anesthesia is commonly utilized for hip replacement surgery. Different medications used for spinal anesthesia work for different lengths of time. This study will compare three different spinal anesthesia medications in patients having hip replacement surgery to see if patients are able to get out of bed and walk earlier after surgery with one medication versus the others.
Eligibility Criteria
Inclusion Criteria
- undergoing elective primary hip replacement surgery
- American Society of Anesthesiologists physical status 1-3
Exclusion Criteria
- hip fracture
- contraindication to spinal anesthesia (refusal, coagulopathy or recent use of anticoagulant medication that prevents spinal anesthesia, local or systemic infection)
- any other reason deemed significant by attending anesthesiologist
- any patient requiring a wheelchair for ambulation or who cannot walk 25 feet with or without an assist device at time of surgery
- presence of neuropathy in posterior thighs or buttocks
- use of greater than the equivalent of morphine 25 mg IV (oxycodone 30 mg PO) daily
- any patient deemed a poor candidate for spinal anesthesia as determined by the attending anesthesiologist
Data sourced from ClinicalTrials.gov (NCT03948386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.