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Recovery PeriodPhase 4NCT07239999

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

A Phase 4 study testing Mepivacaine Injection and Chloroprocaine Injection in people with Recovery Period and Anesthesia, run by Nova Scotia Health Authority.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recovery Period, Anesthesia
What is being tested?
Mepivacaine Injection and Chloroprocaine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
No sites listed yet
Study dates
31 Mar 2026to 15 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

HUSAM M NASHNOUSH, MBBCH, FRCPC contact

001-902-410-9062

husam.nashnoush@nshealth.ca

Mohamed H Nashnoush, MED2 contact

001-902-266-6010

mnashnoush@dal.ca

About this study

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

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.

Being tested
Mepivacaine Injection, Chloroprocaine Injection
Keywords
Spinal anesthesia, Outpatient total knee arthroplasty, Mepivacaine, Chloroprocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mepivacaine InjectionDrug

    Comparing time to motor block recovery in PACU, time to PACU discharge, time to ambulation and length of hospital stay

  • Chloroprocaine InjectionDrug

    Comparing time to motor block recovery in PACU, time to PACU discharge, time to ambulation and length of hospital stay

Study groups in NCT07239999
Study groupRoleWhat they receive
One arm receives spinal Mepivacaine 50 mgActive comparatorOne arm receives spinal Mepivacaine 50mg for total knee arthroplasty with adductor canal block
Receives: Drug: Mepivacaine Injection
Spinal Chloroprocaine groupActive comparatorNot described
Receives: Drug: Chloroprocaine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to complete recovery of motor block

    Measured: 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.

  2. Time to complete motor block recovery of lower limbs after spinal anesthesia

    Motor block will be assessed by PACU nurses in PACU using standard Bromage motor scale.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start31 Mar 2026 (estimated)
  3. Primary completion4 Apr 2027 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07239999
Sponsor's protocol ID
DGH2025
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patient data as Age, sex, BMI, drug doses, time to motor block, time to PACU discharge, time to ambulation, and LOS.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40316299

  • Schwenk ES, Kasper VP, Smoker JD, Mendelson AM, Austin MS, Brown SA, Hozack WJ, Cohen AJ, Li JJ, Wahal CS, Baratta JL, Torjman MC, Nemeth AC, Czerwinski EE. Mepivacaine versus Bupivacaine Spinal Anesthesia for Early Postoperative Ambulation. Anesthesiology. 2020 Oct 1;133(4):801-811. doi: 10.1097/ALN.0000000000003480.

    PubMed 32852904

  • Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.

    PubMed 25211156

  • Siddiqi A, Mahmoud Y, Secic M, Tozzi JM, Emara A, Piuzzi NS, Culp B, Schwarzkopf R, Springer BD, Chen AF. Mepivacaine Versus Bupivacaine Spinal Anesthesia for Primary Total Joint Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2022 Jul;37(7):1396-1404.e5. doi: 10.1016/j.arth.2022.03.031. Epub 2022 Mar 17.

    PubMed 35306162

  • Wyles CC, Pagnano MW, Trousdale RT, Sierra RJ, Taunton MJ, Perry KI, Larson DR, Amundson AW, Smith HM, Duncan CM, Abdel MP. More Predictable Return of Motor Function with Mepivacaine Versus Bupivacaine Spinal Anesthetic in Total Hip and Total Knee Arthroplasty: A Double-Blinded, Randomized Clinical Trial. J Bone Joint Surg Am. 2020 Sep 16;102(18):1609-1615. doi: 10.2106/JBJS.20.00231.

    PubMed 32960532

  • 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.

    PubMed 29429882

  • Camponovo C, Wulf H, Ghisi D, Fanelli A, Riva T, Cristina D, Vassiliou T, Leschka K, Fanelli G. Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Acta Anaesthesiol Scand. 2014 May;58(5):560-6. doi: 10.1111/aas.12291. Epub 2014 Mar 6.

    PubMed 24601887

  • Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.

    PubMed 17377114

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mepivacaine Injection and Chloroprocaine Injection in people with Recovery Period and Anesthesia, run by Nova Scotia Health Authority.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact HUSAM M NASHNOUSH, MBBCH, FRCPC (001-902-410-9062, husam.nashnoush@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07239999, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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