NCT07239999

Brief 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. This could save hospital cost of such procedures.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
14mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

February 6, 2026

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 14, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

Spinal anesthesiaOutpatient total knee arthroplastyMepivacaineChloroprocaine

Outcome Measures

Primary Outcomes (2)

  • Time to complete recovery of motor block

    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

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

    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.

Study Arms (2)

One arm receives spinal Mepivacaine 50 mg

ACTIVE COMPARATOR

One arm receives spinal Mepivacaine 50mg for total knee arthroplasty with adductor canal block

Drug: Mepivacaine Injection

Spinal Chloroprocaine group

ACTIVE COMPARATOR
Drug: Chloroprocaine Injection

Interventions

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

One arm receives spinal Mepivacaine 50 mg

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

Spinal Chloroprocaine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (23)

  • 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: 32509943BACKGROUND
  • 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: 35227811BACKGROUND
  • 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: 27281722BACKGROUND
  • 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: 21203878BACKGROUND
  • 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: 40775385BACKGROUND
  • 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: 36233638BACKGROUND
  • 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: 33610175BACKGROUND
  • 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: 40316299BACKGROUND
  • 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.

    PMID: 32852904BACKGROUND
  • Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.

    PMID: 25211156BACKGROUND
  • 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.

    PMID: 35306162BACKGROUND
  • 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.

    PMID: 32960532BACKGROUND
  • 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: 29429882BACKGROUND
  • 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.

    PMID: 24601887BACKGROUND
  • 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.

    PMID: 17377114BACKGROUND
  • Goldblum E, Atchabahian A. The use of 2-chloroprocaine for spinal anaesthesia. Acta Anaesthesiol Scand. 2013 May;57(5):545-52. doi: 10.1111/aas.12071. Epub 2013 Jan 16.

    PMID: 23320599BACKGROUND
  • Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Impact of Chloroprocaine on the Eligibility for Hospital Discharge in Patients Requiring Ambulatory Surgery Under Spinal Anesthesia: An Observational Multicenter Prospective Study. Adv Ther. 2020 Jan;37(1):541-551. doi: 10.1007/s12325-019-01172-5. Epub 2019 Dec 11.

    PMID: 31828611BACKGROUND
  • Wesselink E, Hurk GJD, Vegt RV, Slagt C, Aa JV, Franssen E, Ven PV, Swart N, Boer C, Leeuw M. Chloroprocaine versus prilocaine for spinal anesthesia in ambulatory knee arthroscopy: a double-blind randomized trial. Reg Anesth Pain Med. 2019 Aug 21:rapm-2019-100673. doi: 10.1136/rapm-2019-100673. Online ahead of print.

    PMID: 31439640BACKGROUND
  • Kim SW, Khandaker R, Muse IO, Pulverenti T, Goman M, Patel J, Yedlin A, Balikai CP, Levine R, Choice C, Montilla Medrano E. Comparison of 1% chloroprocaine hydrochloride versus hyperbaric bupivacaine spinal in patients undergoing anorectal surgery in an ambulatory surgery center: a double-blind randomized clinical trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):324-329. doi: 10.1136/rapm-2024-106130.

    PMID: 39740957BACKGROUND
  • Singh NP, Siddiqui NT, Makkar JK, Guffey R, Singh PM. Optimal local anesthetic for spinal anesthesia in patients undergoing ambulatory non-arthroplasty surgery: a systematic review and Bayesian network meta-analysis of randomized controlled trials. Can J Anaesth. 2025 Apr;72(4):550-566. doi: 10.1007/s12630-025-02924-4. Epub 2025 Apr 8.

    PMID: 40199797BACKGROUND
  • Forget P, Borovac JA, Thackeray EM, Pace NL. Transient neurological symptoms (TNS) following spinal anaesthesia with lidocaine versus other local anaesthetics in adult surgical patients: a network meta-analysis. Cochrane Database Syst Rev. 2019 Dec 1;12(12):CD003006. doi: 10.1002/14651858.CD003006.pub4.

    PMID: 31786810BACKGROUND
  • Khurana BJK, Choudhary S, Singhal M, Rautela RS, Salhotra R, Singh A, Meena S. Comparison of Intrathecal Chloroprocaine With Bupivacaine in Short Gynecological Procedures: A Randomized Double-Blind Study. Cureus. 2023 Aug 27;15(8):e44187. doi: 10.7759/cureus.44187. eCollection 2023 Aug.

    PMID: 37767250BACKGROUND
  • Gu L, Smith CR, Ihnatsenka B, Zasimovich Y, Le-Wendling L. Comparing Spinal Chloroprocaine to Hyperbaric and Isobaric Bupivacaine for Total Hip and Knee Arthroplasties: A Retrospective Study. Cureus. 2023 Mar 3;15(3):e35729. doi: 10.7759/cureus.35729. eCollection 2023 Mar.

    PMID: 37016653BACKGROUND

MeSH Terms

Interventions

Mepivacainechloroprocaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • HUSAM M NASHNOUSH, MBBCH, FRCPC

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HUSAM M NASHNOUSH, MBBCH, FRCPC

CONTACT

Mohamed H Nashnoush, MED2

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Surgeons, PACU Nurses, OR Nurses, Physical therapists
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Husam Nashnoush, MBBCH, FRCPC, Anesthesia Department, Central Zone, DGH, Halifax , NS

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 20, 2025

Study Start

March 31, 2026

Primary Completion (Estimated)

April 4, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

February 6, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Patient data as Age, sex, BMI, drug doses, time to motor block, time to PACU discharge, time to ambulation, and LOS.

Shared Documents
STUDY PROTOCOL
Time Frame
Jan2026 to Jan.2027
Access Criteria
Anesthesia Department, Dalhousie University Research Office
More information