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Not yet recruiting NCT07239999

Comparing Spinal Anesthesia With 1% Chloroprocaine Versus 1% Mepivacaine in Patients Undergoing Outpatient Primary Total Knee Arthroplasty

Phase IV Interventional Recovery Period Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mepivacaine Injection, Chloroprocaine Injection.
Who it may be relevant to
Registry conditions: Recovery Period, Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Controlled Trial Comparing Spinal Anesthesia With 1% Chloroprocaine Versus 1% Mepivacaine in Patients Undergoing Outpatient Primary Total Knee Arthroplasty

Overview

This study or clinical trial looking to compare 2 types of freezing medications injected into the spinal fluid at the lower back between the vertebrae in patients going to have total knee replacement surgery to check for early legs movement, early discharge from recovery room, walking and hospital discharge. This could save hospital cost of such procedures.

Interventions

  • Drug Mepivacaine Injection
    Comparing time to motor block recovery in PACU, time to PACU discharge, time to ambulation and length of hospital stay
  • Drug Chloroprocaine Injection
    Comparing time to motor block recovery in PACU, time to PACU discharge, time to ambulation and length of hospital stay

Primary outcome measures

  • Time to complete recovery of motor block [Time frame: Time from the intrathecal drug injection to the first documented instance of complete motor block recovery Bromage 0. Within approximately 2 hours for the Chloroprocaine group and 4 hours for the Mepivacaine group.]
  • Time to complete motor block recovery of lower limbs after spinal anesthesia [Time frame: From the time of intrathecal drug injection to PACU discharge. Within approximately 3 hours for the Chloroprocaine group and 5 hours for the Mepivacaine group.]

Eligibility criteria

Inclusion criteria

  • ASA I-III
  • Elective outpatient TKA
  • BMI less than 40
  • Ability to provide surgical consent

Exclusion criteria

  • Patient refusal
  • Opioid tolerant
  • Any contraindications to spinal anesthesia
  • Chronic opioid use 3months or more

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Herndon CL, Martinez R, Sarpong NO, Geller JA, Shah RP, Cooper HJ. Spinal Anesthesia Using Chloroprocaine is Safe, Effective, and Facilitates Earlier Discharge in Selected Fast-track Total Hip Arthroplasty. Arthroplast Today. 2020 Jun 1;6(3):305-308. doi: 10.1016/j.artd.2020.04.007. eCollection 2020 Sep. PMID 32509943
  • Callaghan JJ, Mont MA. Editorial: Proceedings of the Knee Society: A Knee Society-Journal of Arthroplasty Collaborative Partnership! J Arthroplasty. 2022 Jun;37(6S):S1. doi: 10.1016/j.arth.2022.02.078. Epub 2022 Feb 26. No abstract available. PMID 35227811
  • Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S. Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):576-83. doi: 10.1097/AAP.0000000000000420. PMID 27281722
  • Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4. PMID 21203878
  • Gilreath N, Liu J, Thomson C, Daher M, Caus S, Dunn H, Antoci V Jr, Barrett T, Cohen E. Retrospective comparison of chloroprocaine and mepivacaine in spinal anesthesia for same-day discharge TKA. Knee Surg Relat Res. 2025 Aug 7;37(1):33. doi: 10.1186/s43019-025-00283-4. PMID 40775385
  • Alhefeiti K, Patrascu AM, Lustig S, Aubrun F, Dziadzko M. Perioperative Outcomes in Patients Who Received Spinal Chloroprocaine for Total Hip or Knee Arthroplasty-Consecutive Case Series Study. J Clin Med. 2022 Sep 29;11(19):5771. doi: 10.3390/jcm11195771. PMID 36233638
  • Ghisi D, Boschetto G, Spinelli AM, Giannone S, Frugiuele J, Ciccarello M, Bonarelli S. Spinal anaesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomised, observer-blind study in adult patients. BMC Anesthesiol. 2021 Feb 20;21(1):58. doi: 10.1186/s12871-021-01279-9. PMID 33610175
  • Pillow CF, Brewbaker C, Wolf BJ, Barrett W, Hansen E, Brown A, Crawford D, Wilson SH. Mepivacaine versus bupivacaine spinal anesthesia for return of motor function following total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2025 May 1:rapm-2024-106342. doi: 10.1136/rapm-2024-106342. Online ahead of print. PMID 40316299

Identifiers

NCT: NCT07239999 · DGH2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗