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Efficacy and Safety of Prilocaine 2% and Lidocaine 5% Hyperbaric Against Spinal Anesthesia in Post Cystoscopy Procedure

NCT ID: NCT05834647

Last Updated: 2023-04-28

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-12-31

Brief Summary

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Regional anesthesia is defined as the temporary removal of nerve conduction and pain in certain areas of the body with local anesthetic drugs without causing loss of consciousness. Spinal anesthesia can provide better analgesia and shorter recovery time in urological procedures resulted in shorter operating times, lower postoperative pain, lower analgesic requirements, and shorter length of stay (LOS) compared to the general anesthesia. Lidocaine is an attractive regional anesthesia drug for ambulatory surgery since it has a rapid onset and rapid recovery from motor and sensory block. However, when it is compared with other local anesthetic agents, the use of lidocaine in spinal anesthesia is associated with an increased risk of transient neurologic symptoms, thus impeding its application to outpatient spinal anesthesia. Lidocaine is more neurotoxic than other local anesthetic agents, especially when high concentrations are applied directly to nervous tissue. Another local anesthetic agent can be used is prilocaine. It has medium potency, rapid duration, and rapid onset of action. Compared with lidocaine, prilocaine has a lower incidence of neurological symptoms in spinal anesthesia for outpatient surgery, and suitable as an alternative to long-acting low-dose local anesthetics. Therefore, the investigators intend to observe the efficacy and safety of these two agents in adult patients who will undergo cystoscopy procedure using spinal anesthesia. In this study the investigators used high-sensitivity C-Reactive Protein (hs-CRP) and high-sensitive Troponin (hs-Troponin). CRP is a systemic inflammation marker associated with conditions such as pain. Troponin can represent patient's kidney function since its metabolism and excretion are affected by changes of estimated glomerular filtration rate (eGFR). Previous study also showed that the use of spinal anesthesia can reduce the incidence of acute kidney injury. Therefore, the investigators aim to carry out further examination of the following two markers regarding to spinal anesthesia using lidocaine and prilocaine.

Detailed Description

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The investigators will conduct a double-blind randomized controlled trial to compare hs-CRP and hs-Troponin levels between prilocaine 2% and hyperbaric lidocaine 5% in adult patients undergoing cystoscopy procedure with spinal anesthesia. This study was approved by the Health Research Ethics Committee (Institutional Review Board) of Dr. Moewardi General Hospital Surakarta. Before randomization, participants who are eligible based on inclusion and exclusion criteria will be given informed consent. If the patients agree, the patient will be included in this research. Ninety adult patients will be randomly divided into control group and treatment group. Control group (group L) will be given 1 mL hyperbaric lidocaine 5% (50 mg) and treatment group (group P) will be given 2.5 mL prilocaine 2% (50 mg) as spinal anesthesia. The investigators will measure hs-CRP serum levels and hs-Troponin serum levels as the primary outcome. Serum levels of hs-CRP dan hs-Troponin will be measured 4 hours postoperative.

Conditions

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Anesthesia; Reaction Anesthesia

Keywords

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hs-CRP Troponin Regional Anesthesia Cystoscopy procedure Lidocaine Prilocaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group P

Drug: prilocaine 2% Dosage : 50 mg prilocaine 2% (2.5 mL volume)

Group Type EXPERIMENTAL

Prilocaine 2%

Intervention Type DRUG

50 mg prilocaine 2% (2.5 mL volume) before undergoing cystoscopy procedure

Group L

Drug: hyperbaric lidocaine 5% Dosage : 50 mg hyperbaric lidocaine 5% (1 mL volume)

Group Type ACTIVE_COMPARATOR

Hyperbaric Lidocaine 5%

Intervention Type DRUG

50 mg Hyperbaric Lidocaine 5% (1.0 mL volume) before undergoing cystoscopy procedure

Interventions

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Prilocaine 2%

50 mg prilocaine 2% (2.5 mL volume) before undergoing cystoscopy procedure

Intervention Type DRUG

Hyperbaric Lidocaine 5%

50 mg Hyperbaric Lidocaine 5% (1.0 mL volume) before undergoing cystoscopy procedure

Intervention Type DRUG

Other Intervention Names

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Takipril Lidodex

Eligibility Criteria

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Inclusion Criteria

1. Patients who will undergo cystoscopy procedure with spinal anesthesia
2. Patients age between 18-60 years
3. Normal BMI according to WHO (World Health Organization) classification (18.5-24.9 kg/m2)
4. Physical status ASA (American Society of Anesthesiologists) I or ASA II according to the ASA Physical Status Classification System by the American Society of Anesthesiologists in 2020.
5. Do not have a history of disease, medication, and medical procedures related to coronary heart disease
6. There are no absolute contraindications for spinal anesthesia
7. Do not take non-steroidal analgesics and steroids within 2 weeks before surgery.
8. Do not have history and treatment of Diabetes Mellitus.
9. Willing to participate in research and sign informed consent

Exclusion Criteria

1. Has been or will be included in other research.
2. Have a direct relative with the research team.
3. Known or suspected to HIV infection.
4. History of hypersensitivity to prilocaine or lidocaine.
5. Patients with impaired renal, hepatic, cardiac rhythm, neurologic function, myopathy, thrombocytopenia (\<100,000/mL), and coagulopathy (international normalized ratio \>1.5)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia Endowment Fund for Education

UNKNOWN

Sponsor Role collaborator

Universitas Sebelas Maret

OTHER

Sponsor Role lead

Responsible Party

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Septian Adi Permana. MD

Staff Department of Anesthesiology and Intensive Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Purwoko Purwoko, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitas Sebelas Maret

Central Contacts

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Septian A Permana, Intensivist

Role: CONTACT

Phone: +6281393724000

Email: [email protected]

Ageng Sunjoyo, MD

Role: CONTACT

Phone: +62811250503

Email: [email protected]

References

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Afari N, Mostoufi S, Noonan C, Poeschla B, Succop A, Chopko L, Strachan E. C-reactive protein and pain sensitivity: findings from female twins. Ann Behav Med. 2011 Oct;42(2):277-83. doi: 10.1007/s12160-011-9297-6.

Reference Type RESULT
PMID: 21785898 (View on PubMed)

Banerjee D, Perrett C, Banerjee A. Troponins, Acute Coronary Syndrome and Renal Disease: From Acute Kidney Injury Through End-stage Kidney Disease. Eur Cardiol. 2019 Dec 18;14(3):187-190. doi: 10.15420/ecr.2019.28.2. eCollection 2019 Dec.

Reference Type RESULT
PMID: 31933690 (View on PubMed)

Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.

Reference Type RESULT
PMID: 22822998 (View on PubMed)

Choi HR, Song IA, Oh TK, Jeon YT. Perioperative C-reactive protein is associated with pain outcomes after major laparoscopic abdominal surgery: a retrospective analysis. J Pain Res. 2019 Mar 27;12:1041-1051. doi: 10.2147/JPR.S187249. eCollection 2019.

Reference Type RESULT
PMID: 31114292 (View on PubMed)

Ezmek B, Arslan A, Delilbasi C, Sencift K. Comparison of hemodynamic effects of lidocaine, prilocaine and mepivacaine solutions without vasoconstrictor in hypertensive patients. J Appl Oral Sci. 2010 Jul-Aug;18(4):354-9. doi: 10.1590/s1678-77572010000400006.

Reference Type RESULT
PMID: 20835569 (View on PubMed)

Garg P, Morris P, Fazlanie AL, Vijayan S, Dancso B, Dastidar AG, Plein S, Mueller C, Haaf P. Cardiac biomarkers of acute coronary syndrome: from history to high-sensitivity cardiac troponin. Intern Emerg Med. 2017 Mar;12(2):147-155. doi: 10.1007/s11739-017-1612-1. Epub 2017 Feb 11.

Reference Type RESULT
PMID: 28188579 (View on PubMed)

Hu H, Qin B, He D, Lu Y, Zhao Z, Zhang J, Wang Y, Wang S. Regional versus General Anesthesia for Percutaneous Nephrolithotomy: A Meta-Analysis. PLoS One. 2015 May 11;10(5):e0126587. doi: 10.1371/journal.pone.0126587. eCollection 2015.

Reference Type RESULT
PMID: 25961831 (View on PubMed)

Kato J, Svensson CI. Role of extracellular damage-associated molecular pattern molecules (DAMPs) as mediators of persistent pain. Prog Mol Biol Transl Sci. 2015;131:251-79. doi: 10.1016/bs.pmbts.2014.11.014. Epub 2015 Jan 30.

Reference Type RESULT
PMID: 25744676 (View on PubMed)

Koo CH, Ryu JH. Anesthetic considerations for urologic surgeries. Korean J Anesthesiol. 2020 Apr;73(2):92-102. doi: 10.4097/kja.19437. Epub 2019 Dec 17.

Reference Type RESULT
PMID: 31842248 (View on PubMed)

Manassero A, Fanelli A. Prilocaine hydrochloride 2% hyperbaric solution for intrathecal injection: a clinical review. Local Reg Anesth. 2017 Mar 31;10:15-24. doi: 10.2147/LRA.S112756. eCollection 2017.

Reference Type RESULT
PMID: 28408851 (View on PubMed)

Reece AS. High-sensitivity CRP in opiate addiction: relative and age-dependent elevations. Cardiovasc Toxicol. 2012 Jun;12(2):149-57. doi: 10.1007/s12012-012-9154-2.

Reference Type RESULT
PMID: 22297435 (View on PubMed)

Uher T, Bob P. Neuropathic pain, depressive symptoms, and C-reactive protein in sciatica patients. Int J Neurosci. 2013 Mar;123(3):204-8. doi: 10.3109/00207454.2012.746335.

Reference Type RESULT
PMID: 23126320 (View on PubMed)

Freda BJ, Tang WH, Van Lente F, Peacock WF, Francis GS. Cardiac troponins in renal insufficiency: review and clinical implications. J Am Coll Cardiol. 2002 Dec 18;40(12):2065-71. doi: 10.1016/s0735-1097(02)02608-6.

Reference Type RESULT
PMID: 12505215 (View on PubMed)

Kelley WE, Januzzi JL, Christenson RH. Increases of cardiac troponin in conditions other than acute coronary syndrome and heart failure. Clin Chem. 2009 Dec;55(12):2098-112. doi: 10.1373/clinchem.2009.130799. Epub 2009 Oct 8.

Reference Type RESULT
PMID: 19815610 (View on PubMed)

Kula A, Bansal N. Applications of cardiac biomarkers in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Nov 1;31(6):534-540. doi: 10.1097/MNH.0000000000000829. Epub 2022 Aug 4.

Reference Type RESULT
PMID: 36004954 (View on PubMed)

Related Links

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https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca454f96-2e2d-46ed-95af-c741726773de

US National Institutes of Health, 2010. PRILOCAINE HYDROCHLORIDE injection, solution

https://pubchem.ncbi.nlm.nih.gov/compound/4906

National Center for Biotechnology Information, 2022. Prilocaine

Other Identifiers

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ANES/PR/001

Identifier Type: -

Identifier Source: org_study_id