3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty

NCT03948386 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19D.299
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Percentage Ambulating Early After Spinal Anesthesia

  Is there a difference between isobaric mepivacaine, hyperbaric bupivacaine, and isobaric bupivacaine when used for spinal anesthesia in primary total hip replacement in percentage of patients that can ambulate within 3.5 hours after spinal anesthesia?

  3.5 hours

Secondary Outcomes (5)

• Return of Motor Function of the Thigh and Lower Leg

  Postoperative day 0 (day of surgery)

• Number of Patients With Dizziness Events

  Postoperative day 2

• Number of Patients With Urinary Retention Events

  postoperative day 1

• Number of Patients With Transient Neurological Symptoms (TNS)

  Postoperative days 0-2

• Hospital Stay

  hospital stay (0-3 days)

Study Arms (3)

isobaric bupivacaine

ACTIVE COMPARATOR

Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height

Drug: isobaric bupivacaine

hyperbaric bupivacaine

ACTIVE COMPARATOR

hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height

Drug: hyperbaric bupivacaine

isobaric mepivacaine

ACTIVE COMPARATOR

isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height

Drug: isobaric mepivacaine

Interventions

isobaric bupivacaine DRUG

The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.

isobaric bupivacaine

hyperbaric bupivacaine DRUG

TThe anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.

hyperbaric bupivacaine

isobaric mepivacaine DRUG

The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.

isobaric mepivacaine

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing elective primary hip replacement surgery
• American Society of Anesthesiologists physical status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Rothman Orthopedic Specialty Hospital

Bensalem, Pennsylvania, 19020, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (9)

• Basques BA, Toy JO, Bohl DD, Golinvaux NS, Grauer JN. General compared with spinal anesthesia for total hip arthroplasty. J Bone Joint Surg Am. 2015 Mar 18;97(6):455-61. doi: 10.2106/JBJS.N.00662.

  PMID: 25788301 BACKGROUND

• Kamel HK, Iqbal MA, Mogallapu R, Maas D, Hoffmann RG. Time to ambulation after hip fracture surgery: relation to hospitalization outcomes. J Gerontol A Biol Sci Med Sci. 2003 Nov;58(11):1042-5. doi: 10.1093/gerona/58.11.m1042.

  PMID: 14630887 BACKGROUND

• Oldmeadow LB, Edwards ER, Kimmel LA, Kipen E, Robertson VJ, Bailey MJ. No rest for the wounded: early ambulation after hip surgery accelerates recovery. ANZ J Surg. 2006 Jul;76(7):607-11. doi: 10.1111/j.1445-2197.2006.03786.x.

  PMID: 16813627 BACKGROUND

• Mahan MC, Jildeh TR, Tenbrunsel TN, Davis JJ. Mepivacaine Spinal Anesthesia Facilitates Rapid Recovery in Total Knee Arthroplasty Compared to Bupivacaine. J Arthroplasty. 2018 Jun;33(6):1699-1704. doi: 10.1016/j.arth.2018.01.009. Epub 2018 Jan 16.

  PMID: 29429882 BACKGROUND

• Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.

  PMID: 28708665 BACKGROUND

• Pawlowski J, Orr K, Kim KM, Pappas AL, Sukhani R, Jellish WS. Anesthetic and recovery profiles of lidocaine versus mepivacaine for spinal anesthesia in patients undergoing outpatient orthopedic arthroscopic procedures. J Clin Anesth. 2012 Mar;24(2):109-15. doi: 10.1016/j.jclinane.2011.06.014. Epub 2012 Feb 17.

  PMID: 22342508 BACKGROUND

• Pawlowski J, Sukhani R, Pappas AL, Kim KM, Lurie J, Gunnerson H, Corsino A, Frey K, Tonino P. The anesthetic and recovery profile of two doses (60 and 80 mg) of plain mepivacaine for ambulatory spinal anesthesia. Anesth Analg. 2000 Sep;91(3):580-4. doi: 10.1097/00000539-200009000-00015.

  PMID: 10960380 BACKGROUND

• Liguori GA, Zayas VM, Chisholm MF. Transient neurologic symptoms after spinal anesthesia with mepivacaine and lidocaine. Anesthesiology. 1998 Mar;88(3):619-23. doi: 10.1097/00000542-199803000-00010.

  PMID: 9523803 BACKGROUND

• YaDeau JT, Liguori GA, Zayas VM. The incidence of transient neurologic symptoms after spinal anesthesia with mepivacaine. Anesth Analg. 2005 Sep;101(3):661-665. doi: 10.1213/01.ane.0000167636.94707.d3.

  PMID: 16115971 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Eric S Schwenk, MD
• Organization: Thomas Jefferson University

eric.schwenk@jefferson.edu

215-955-6161

Study Officials

• Eric Schwenk, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist and certified registered nurse anesthetist or resident performing the spinal will be aware of group allocation and will perform spinal anesthesia according to standard operating procedures with the assigned local anesthetic. Patients will remain blinded and surgeons and those performing postoperative assessments will remain blinded as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who agree to participate will then be randomized by a computer-generated sequence to one of the three study groups. Dosing will be as follows: isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height; hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height; and isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: May 13, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-04

Locations

US (2)