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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05834647
• Other study ID #: ANES/PR/001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Universitas Sebelas Maret
• Contact: Septian A Permana, Intensivist
• Phone: +6281393724000
• Email: septian.adi03[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia; Reaction

Intervention

Drug:
• Prilocaine 2%
50 mg prilocaine 2% (2.5 mL volume) before undergoing cystoscopy procedure
• Hyperbaric Lidocaine 5%
50 mg Hyperbaric Lidocaine 5% (1.0 mL volume) before undergoing cystoscopy procedure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Sebelas Maret	Indonesia Endowment Fund for Education

References & Publications (15)

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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. — View Citation

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. — View Citation

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. — View Citation

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/s1678-775720100004000 — View Citation

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. — View Citation

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/s11739-01 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Through Study Completion, an average of 1 day
Secondary	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; : just able to flex knees with free movement of feet with 33% (partial) blockade; : unable to flex knee, but with free movement of feet with 66% (almost complete) blockade; : unable to move legs or feet with 100% (complete) blockade	Through Study Completion, an average of 1 day
Secondary	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.	Through Study Completion, an average of 1 day
Secondary	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	Through Study Completion, an average of 1 day
Secondary	The incidence of adverse effects of bradycardia	Bradycardia will be defined as heart rate < 50 beat/min	Through Study Completion, an average of 1 day
Secondary	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).	Through Study Completion, an average of 1 day

External Links

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