drugset / Trial / NCT03324984
1% Chloroprocaine(PF) vs. Bupivacaine Spinals
RandomizedParallel-groupTriple-blindTreatment
Summary
The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 2-Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 2-Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group.
Timeline
- Start
- 2019-09-11
- Primary completion
- 2023-02-01
- Completion
- 2023-02-01
Outcome
Mixed primary results
paper There were no significant differences between interventions for recovery time. PMID 39740957 ↗
paper The chloroprocaine group had a significantly shorter time to meet discharge criteria (191.4±6.6 min) than the bupivacaine group (230.9±9.4 min; p=<0.001). PMID 39740957 ↗
Publications
- Background Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.
- Background Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005 Dec;101(6):1634-1642. doi: 10.1213/01.ANE.0000180829.70036.4F.
- Background Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
- Background Pollock JE. Transient neurologic symptoms: etiology, risk factors, and management. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):581-6. doi: 10.1053/rapm.2002.36457. No abstract available.
- Background Fanelli A, Ghisi D, Allegri M. Is spinal anaesthesia a suitable technique for ultra-short outpatient procedures? Acta Biomed. 2013 Jun 1;84(1):76-80.
- Background Smith KN, Kopacz DJ, McDonald SB. Spinal 2-chloroprocaine: a dose-ranging study and the effect of added epinephrine. Anesth Analg. 2004 Jan;98(1):81-88. doi: 10.1213/01.ANE.0000093361.48458.6E.
- Background Vath JS, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added fentanyl. Anesth Analg. 2004 Jan;98(1):89-94. doi: 10.1213/01.ANE.0000093360.02058.ED.
- Background Kouri ME, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with lidocaine in volunteers. Anesth Analg. 2004 Jan;98(1):75-80. doi: 10.1213/01.ANE.0000093228.61443.EE.
- Background Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine for surgery: an initial 10-month experience. Anesth Analg. 2005 Feb;100(2):553-558. doi: 10.1213/01.ANE.0000130397.38849.4A.
- Background Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x.
- Background Pavlin DJ, Pavlin EG, Fitzgibbon DR, Koerschgen ME, Plitt TM. Management of bladder function after outpatient surgery. Anesthesiology. 1999 Jul;91(1):42-50. doi: 10.1097/00000542-199907000-00010.
- Background Mulroy MF. Outpatients do not need to void after short neuraxial blocks. Anesthesiology. 2009 Dec;111(6):1388; author reply 1389. doi: 10.1097/ALN.0b013e3181bfa8d3. No abstract available.
- Background 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.
- Background 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.75 % | Other |
| Subject | Chloroprocaine | Other / unclassified | 1 % | Other |
Indications
No indication recorded.