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

NCT05834647 | Unknown Phase 4

• 1 other identifier: ANES/PR/001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia; Reaction; Anesthesia

Keywords

hs-CRP; Troponin; Regional Anesthesia; Cystoscopy procedure; Lidocaine; Prilocaine

Outcome Measures

Primary Outcomes (2)

• hs-CRP serum level

  hs-CRP serum concentration will be measured using particle enhanced immunoturbidimetry method as indicator of inflammatory biomarker resulted from pain due to surgery.

  4 hours postoperative

• hs-Troponin serum level

  Serum hs-Troponin at 4 hours postoperative \[ Time Frame: 4 hours postoperative \] hs-Troponin serum concentration will be measured using Enzyme-Linked Fluorescent Assay (ELFA) method as indicator of kidney injury comparing lidocain 5% hyperbaric and prilocaine 2%

  4 hours postoperative

Secondary Outcomes (6)

• Full regression of sensory block

  Through Study Completion, an average of 1 day

• Duration of PACU (Post-Anaesthesia Care Unit) stay

  Through Study Completion, an average of 1 day

• Pain score after cystoscopy procedure

  Through Study Completion, an average of 1 day

• The incidence of adverse effects of hypotension

  Through Study Completion, an average of 1 day

• The incidence of adverse effects of bradycardia

  Through Study Completion, an average of 1 day

Study Arms (2)

Group P

EXPERIMENTAL

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

Drug: Prilocaine 2%

Group L

ACTIVE COMPARATOR

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

Drug: Hyperbaric Lidocaine 5%

Interventions

Prilocaine 2% DRUG

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

Also known as: Takipril

Group P

Hyperbaric Lidocaine 5% DRUG

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

Also known as: Lidodex

Group L

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who will undergo cystoscopy procedure with spinal anesthesia
• Patients age between 18-60 years
• Normal BMI according to WHO (World Health Organization) classification (18.5-24.9 kg/m2)
• 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.
• Do not have a history of disease, medication, and medical procedures related to coronary heart disease
• There are no absolute contraindications for spinal anesthesia
• Do not take non-steroidal analgesics and steroids within 2 weeks before surgery.
• Do not have history and treatment of Diabetes Mellitus.
• Willing to participate in research and sign informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Sebelas Maret: lead
• Indonesia Endowment Fund for Education: collaborator

Related Publications (15)

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• 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.

  PMID: 36004954 RESULT

Related Links

• US National Institutes of Health, 2010. PRILOCAINE HYDROCHLORIDE injection, solution
• National Center for Biotechnology Information, 2022. Prilocaine

Study Officials

• Purwoko Purwoko, PhD

  Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Septian A Permana, Intensivist

CONTACT

+6281393724000; septian.adi03@gmail.com

Ageng Sunjoyo, MD

CONTACT

+62811250503; ageng.sunjoyo1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Department of Anesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 28, 2023
• Study Start: August 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share