Epidural Anesthesia With Chloroprocaine Versus Lidocaine

NCT02287870 | Completed Phase 4 DMC

• 1 other identifier: 2007NLY-004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a short time, provides fast motor recovery and causes no significant side effects.

Conditions

Anesthesia

Keywords

Epidural anesthesia; Chloroprocaine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Epidural anesthesia effects of chloroprocaine versus lidocaine

  The effects of epidural anesthesia are assessed by onset time of epidural block, pain free and recovery time, the upper block level and time, the degree of muscle relaxation, and motor recovery time.

  Four months (January - April, 2008)

Secondary Outcomes (1)

• Comparison of vital signs between chloroprocaine and lidocaine groups

  Four months (January - April, 2008)

Study Arms (2)

Chloroprocaine Group

EXPERIMENTAL

Epidural anesthesia with 3% chloroprocaine.

Drug: Chloroprocaine

Lidocaine Group

ACTIVE COMPARATOR

Epidural anesthesia with 2% lidocaine.

Drug: Lidocaine

Interventions

Chloroprocaine DRUG

60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine.

Also known as: Chloroprocaine Hydrochloride

Chloroprocaine Group

Lidocaine DRUG

60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine.

Also known as: Lidocaine Hydrochloride

Lidocaine Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Weight no more than 80 Kg or not more than 20% of normal weight
• American Society of Anesthesiologists (ASA) grade I or II
• No obstacles in thinking or language communication
• No epidural puncture contraindications such as disturbances of blood coagulation, local infection of the puncture site or use of anticoagulants

You may not qualify if:

• Chronic obstructive pulmonary diseases
• Serious heart, liver, renal and metabolic diseases
• Cerebral thrombosis and sequela
• Serious dehydration and electrolyte imbalance
• Neuromuscular diseases
• Pregnant or parturient women
• Abnormal liver and kidney function

Sponsors & Collaborators

• Jinling Hospital, China: lead

Related Publications (10)

• FOLDES FF, McNALL PG. 2-Chloroprocaine: a new local anesthetic agent. Anesthesiology. 1952 May;13(3):287-96. doi: 10.1097/00000542-195205000-00009. No abstract available.

  PMID: 14933832 BACKGROUND

• Steinemann TL, Sheikholeslami RR, Klein EF, Prokopius MJ. Short-acting peribulbar anesthesia with 2-chloroprocaine. J Cataract Refract Surg. 2002 Jan;28(1):195-6. doi: 10.1016/s0886-3350(01)00899-9.

  PMID: 11777732 BACKGROUND

• Hadzic A, Arliss J, Kerimoglu B, Karaca PE, Yufa M, Claudio RE, Vloka JD, Rosenquist R, Santos AC, Thys DM. A comparison of infraclavicular nerve block versus general anesthesia for hand and wrist day-case surgeries. Anesthesiology. 2004 Jul;101(1):127-32. doi: 10.1097/00000542-200407000-00020.

  PMID: 15220781 BACKGROUND

• Liu SS, Ware PD, Rajendran S. Effects of concentration and volume of 2-chloroprocaine on epidural anesthesia in volunteers. Anesthesiology. 1997 Jun;86(6):1288-93; discussion 7A. doi: 10.1097/00000542-199706000-00009.

  PMID: 9197297 BACKGROUND

• Sell A, Tein T, Pitkanen M. Spinal 2-chloroprocaine: effective dose for ambulatory surgery. Acta Anaesthesiol Scand. 2008 May;52(5):695-9. doi: 10.1111/j.1399-6576.2008.01639.x.

  PMID: 18419724 BACKGROUND

• Marica LS, O'Day T, Janosky JE, Nystrom EU. Chloroprocaine is less painful than lidocaine for skin infiltration anesthesia. Anesth Analg. 2002 Feb;94(2):351-4, table of contents. doi: 10.1097/00000539-200202000-00022.

  PMID: 11812697 RESULT

• Marsch SC, Sluga M, Studer W, Barandun J, Scharplatz D, Ummenhofer W. 0.5% versus 1.0% 2-chloroprocaine for intravenous regional anesthesia: a prospective, randomized, double-blind trial. Anesth Analg. 2004 Jun;98(6):1789-1793. doi: 10.1213/01.ANE.0000116929.45557.CE.

  PMID: 15155349 RESULT

• Jafari S, Kalstein AI, Nasrullah HM, Hedayatnia M, Yarmush JM, SchianodiCola J. A randomized, prospective, double-blind trial comparing 3% chloroprocaine followed by 0.5% bupivacaine to 2% lidocaine followed by 0.5% bupivacaine for interscalene brachial plexus block. Anesth Analg. 2008 Nov;107(5):1746-50. doi: 10.1213/ane.0b013e318185cd5e.

  PMID: 18931242 RESULT

• Bjornestad E, Iversen OL, Raeder J. Similar onset time of 2-chloroprocaine and lidocaine + epinephrine for epidural anesthesia for elective Cesarean section. Acta Anaesthesiol Scand. 2006 Mar;50(3):358-63. doi: 10.1111/j.1399-6576.2006.00937.x.

  PMID: 16480471 RESULT

• 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: 17377114 RESULT

MeSH Terms

Interventions

chloroprocaine; Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Weiyan Li, M.D.

  School of Medicine, Nanjing University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor of Department of Anesthesiology

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 11, 2014
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 11, 2014

Record last verified: 2014-11