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AnesthesiaPhase 4NCT02287870

Epidural Anesthesia With Chloroprocaine Versus Lidocaine

A Phase 4 study testing Chloroprocaine and Lidocaine in people with Anesthesia, run by Jinling Hospital, China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Anesthesia
What is being tested?
Chloroprocaine and Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jan 2008to Jun 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Low Epidural Anesthesia With Chloroprocaine Versus Lidocaine: a Prospective, Randomized, Double-blinded Multi-centre Clinical Trial in China

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.

Read the detailed description

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
Anesthesia
Being tested
Chloroprocaine, Lidocaine
Keywords
Epidural anesthesia, Chloroprocaine, Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChloroprocaineDrug

    Also called Chloroprocaine Hydrochloride

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

  • LidocaineDrug

    Also called Lidocaine Hydrochloride

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

Study groups in NCT02287870
Study groupRoleWhat they receive
Chloroprocaine GroupExperimentalEpidural anesthesia with 3% chloroprocaine.
Receives: Drug: Chloroprocaine
Lidocaine GroupActive comparatorEpidural anesthesia with 2% lidocaine.
Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Four months (January - April, 2008)

Secondary outcomes (1)

  1. Comparison of vital signs between chloroprocaine and lidocaine groups

    The vital signs are assessed by diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse oxygen saturation (SpO2).

    Measured: Four months (January - April, 2008)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2014 (estimated)
  2. Study startJan 2008
  3. Primary completionApr 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02287870
Sponsor's protocol ID
2007NLY-004
Status last verified
Nov 2014
First submitted
4 Nov 2014
Last updated
11 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14933832

  • 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.

    PubMed 11777732

  • 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.

    PubMed 15220781

  • 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.

    PubMed 9197297

  • 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.

    PubMed 18419724

  • 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.

    PubMed 11812697

  • 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.

    PubMed 15155349

  • 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.

    PubMed 18931242

  • 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.

    PubMed 16480471

  • 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.

    PubMed 17377114

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Chloroprocaine and Lidocaine in people with Anesthesia, run by Jinling Hospital, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epidural anesthesia effects of chloroprocaine versus lidocaine (time frame: Four months (January - April, 2008)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02287870, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.

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