Epidural Anesthesia With Chloroprocaine Versus Lidocaine

NCT ID: NCT02287870

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Chloroprocaine hydrochloride is the chloridized local anesthetic of procaine hydrochloride, with twice the anesthetic intensity, four to five times the metabolization and half the side effect of procaine. The chloroprocaine hydrochloride product made in China has been on sale since 2002. To determine the clinical efficacy of low-epidural anesthesia with chloroprocaine versus lidocaine, the investigators carried out a prospective, randomized, double-blinded multi-centre clinical trial. The results demonstrate that epidural anesthesia using chloroprocaine has a more rapid onset time and shorter duration than with lidocaine. It can also provide a reliable sensory and motor block in epidural anesthesia, and is thus a more attractive alternative than lidocaine for middle and short duration surgical procedures.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Chloroprocaine Group

Epidural anesthesia with 3% chloroprocaine.

Group Type EXPERIMENTAL

Chloroprocaine

Intervention Type DRUG

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

Lidocaine Group

Epidural anesthesia with 2% lidocaine.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Interventions

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Chloroprocaine

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

Intervention Type DRUG

Lidocaine

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

Intervention Type DRUG

Other Intervention Names

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Chloroprocaine Hydrochloride Lidocaine Hydrochloride

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Haibin Dai

Attending Doctor of Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiyan Li, M.D.

Role: STUDY_DIRECTOR

School of Medicine, Nanjing University

References

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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.

Reference Type BACKGROUND
PMID: 14933832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11777732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15220781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9197297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18419724 (View on PubMed)

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.

Reference Type RESULT
PMID: 11812697 (View on PubMed)

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.

Reference Type RESULT
PMID: 15155349 (View on PubMed)

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.

Reference Type RESULT
PMID: 18931242 (View on PubMed)

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.

Reference Type RESULT
PMID: 16480471 (View on PubMed)

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.

Reference Type RESULT
PMID: 17377114 (View on PubMed)

Other Identifiers

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2007NLY-004

Identifier Type: -

Identifier Source: org_study_id