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Anesthesia; ReactionPhase 4NCT05834647

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

A Phase 4 study testing Prilocaine 2% and Hyperbaric Lidocaine 5% in people with Anesthesia; Reaction and Anesthesia, run by Universitas Sebelas Maret.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia; Reaction, Anesthesia
What is being tested?
Prilocaine 2% and Hyperbaric Lidocaine 5%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
1 Aug 2023to 31 Dec 2023
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet.

Septian A Permana, Intensivist contact

+6281393724000

septian.adi03@gmail.com

Ageng Sunjoyo, MD contact

+62811250503

ageng.sunjoyo1@gmail.com

About this study

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.

Read the detailed description

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.

Being tested
Prilocaine 2%, Hyperbaric Lidocaine 5%
Keywords
hs-CRP, Troponin, Regional Anesthesia, Cystoscopy procedure, Lidocaine, Prilocaine

What participants receive

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

  • Prilocaine 2%Drug

    Also called Takipril

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

  • Hyperbaric Lidocaine 5%Drug

    Also called Lidodex

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

Study groups in NCT05834647
Study groupRoleWhat they receive
Group PExperimentalDrug: prilocaine 2% Dosage : 50 mg prilocaine 2% (2.5 mL volume)
Receives: Drug: Prilocaine 2%
Group LActive comparatorDrug: hyperbaric lidocaine 5% Dosage : 50 mg hyperbaric lidocaine 5% (1 mL volume)
Receives: Drug: Hyperbaric Lidocaine 5%

What is being measured

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

  1. 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.

    Measured: 4 hours postoperative

  2. 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%

    Measured: 4 hours postoperative

Secondary outcomes (6)

  1. Full regression of sensory block

    Full regression of sensory block, defined as the duration (in minutes) between intrathecal drug injection and appearance of first pain sensation reported by patients and will be confirmed by using Visual Analogue Scale. The Visual Analogue Scale (VAS) is a 10 cm or 100 mm line with anchor statements on the left scale 0 represents no pain and on the right scale 10 (or 100) represents an extreme pain. The patient is asked to mark their current pain level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.

    Measured: Through Study Completion, an average of 1 day

  2. Duration of PACU (Post-Anaesthesia Care Unit) stay

    Duration of PACU stay in minutes based on Bromage scale. Patients will be discharged from PACU if Bromage Scale <2. Bromage scale is most commonly used, although this represents only lumbosacral motor fibers and have grading scale as follow:

    0 : free movement of legs and feet with 0% blockade

    1. : just able to flex knees with free movement of feet with 33% (partial) blockade
    2. : unable to flex knee, but with free movement of feet with 66% (almost complete) blockade
    3. : unable to move legs or feet with 100% (complete) blockade

    Measured: Through Study Completion, an average of 1 day

  3. Pain score after cystoscopy procedure

    Pain score after cystoscopy procedure comparing administration of lidocaine 5% hyperbaric and prilocaine 2% using visual analogue scale (VAS) on a 100- mm VAS. The Visual Analogue Scale (VAS) is a 10 cm or 100 mm line with anchor statements on the left scale 0 represents no pain and on the right scale 10 (or 100) represents an extreme pain. The patient is asked to mark their current pain level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.

    Measured: Through Study Completion, an average of 1 day

  4. The incidence of adverse effects of hypotension

    Hypotension will be defined as a systolic blood pressure of < 90 mmHg or a decrease in mean arterial pressure (MAP in mmHg) of more than 20% from baseline preoperative value. MAP is measured from formula [(2xsystolic pressure in mmHg) + diastolic pressure in mmHg)] / 3

    Measured: Through Study Completion, an average of 1 day

  5. The incidence of adverse effects of bradycardia

    Bradycardia will be defined as heart rate < 50 beat/min

    Measured: Through Study Completion, an average of 1 day

  6. The incidence of adverse effects of nausea.

    Nausea will be assessed using (Visual Analogue Scale) VAS score for PONV (Postoperative Nausea and Vomiting). The severity of nausea was divided into four groups based on the VAS scale: 0-1 (no nausea), 1-4 (mild), 4-7 (moderate) and 7-10 (severe).

    Measured: Through Study Completion, an average of 1 day

Timeline

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

  1. First posted28 Apr 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

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
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05834647
Sponsor's protocol ID
ANES/PR/001
Status last verified
Apr 2023
First submitted
29 Mar 2023
Last updated
28 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21785898

  • 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.

    PubMed 31933690

  • 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.

    PubMed 22822998

  • 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.

    PubMed 31114292

  • 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.

    PubMed 20835569

  • 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.

    PubMed 28188579

  • 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.

    PubMed 25961831

  • 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.

    PubMed 25744676

  • 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.

    PubMed 31842248

  • 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.

    PubMed 28408851

  • 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.

    PubMed 22297435

  • 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.

    PubMed 23126320

  • 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.

    PubMed 12505215

  • 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.

    PubMed 19815610

  • 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.

    PubMed 36004954

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prilocaine 2% and Hyperbaric Lidocaine 5% in people with Anesthesia; Reaction and Anesthesia, run by Universitas Sebelas Maret.

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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. 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?

Results are not available in the source record.

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

Contact Septian A Permana, Intensivist (+6281393724000, septian.adi03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hs-CRP serum level (time frame: 4 hours postoperative). The study lists 2 primary outcomes in all. 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 NCT05834647, which also lists 15 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 28 Apr 2023.

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