- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239999
Comparing Spinal Anesthesia With 1% Chloroprocaine Versus 1% Mepivacaine in Patients Undergoing Outpatient Primary Total Knee Arthroplasty
February 4, 2026 updated by: Husam Nashnoush, Nova Scotia Health Authority
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
170
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HUSAM M NASHNOUSH, MBBCH, FRCPC
- Phone Number: 001-902-410-9062
- Email: husam.nashnoush@nshealth.ca
Study Contact Backup
- Name: Mohamed H Nashnoush, MED2
- Phone Number: 001-902-266-6010
- Email: mnashnoush@dal.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: One arm receives spinal Mepivacaine 50 mg
One arm receives spinal Mepivacaine 50mg for total knee arthroplasty with adductor canal block
|
Comparing time to motor block recovery in PACU, time to PACU discharge, time to ambulation and length of hospital stay
|
|
Active Comparator: Spinal Chloroprocaine group
|
Comparing time to motor block recovery in PACU, time to PACU discharge, time to ambulation and length of hospital stay
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: HUSAM M NASHNOUSH, MBBCH, FRCPC, Dalhousie University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 2024 Dec 31:rapm-2024-106130. doi: 10.1136/rapm-2024-106130. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 31, 2026
Primary Completion (Estimated)
April 4, 2027
Study Completion (Estimated)
June 15, 2027
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
February 6, 2026
Last Update Submitted That Met QC Criteria
February 4, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGH2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient data as Age, sex, BMI, drug doses, time to motor block, time to PACU discharge, time to ambulation, and LOS.
IPD Sharing Time Frame
Jan2026 to Jan.2027
IPD Sharing Access Criteria
Anesthesia Department, Dalhousie University Research Office
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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