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

Sponsor

Universitas Sebelas Maret (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05834647

Collaborator

Indonesia Endowment Fund for Education (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Reaction Anesthesia	Drug: Prilocaine 2% Drug: Hyperbaric Lidocaine 5%	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group P Drug: prilocaine 2% Dosage : 50 mg prilocaine 2% (2.5 mL volume)	Drug: Prilocaine 2% 50 mg prilocaine 2% (2.5 mL volume) before undergoing cystoscopy procedure Other Names: Takipril
Active Comparator: Group L Drug: hyperbaric lidocaine 5% Dosage : 50 mg hyperbaric lidocaine 5% (1 mL volume)	Drug: Hyperbaric Lidocaine 5% 50 mg Hyperbaric Lidocaine 5% (1.0 mL volume) before undergoing cystoscopy procedure Other Names: Lidodex

Arm

Intervention/Treatment

Experimental: Group P

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

Drug: Prilocaine 2%

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

Other Names:

Takipril

Active Comparator: Group L

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

Drug: Hyperbaric Lidocaine 5%

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

Other Names:

Lidodex

Outcome Measures

Primary Outcome Measures

hs-CRP serum level [4 hours postoperative]
hs-CRP serum concentration will be measured using particle enhanced immunoturbidimetry method as indicator of inflammatory biomarker resulted from pain due to surgery.
hs-Troponin serum level [4 hours postoperative]
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%

Secondary Outcome Measures

Full regression of sensory block [Through Study Completion, an average of 1 day]
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.
Duration of PACU (Post-Anaesthesia Care Unit) stay [Through Study Completion, an average of 1 day]
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
Pain score after cystoscopy procedure [Through Study Completion, an average of 1 day]
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.
The incidence of adverse effects of hypotension [Through Study Completion, an average of 1 day]
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
The incidence of adverse effects of bradycardia [Through Study Completion, an average of 1 day]
Bradycardia will be defined as heart rate < 50 beat/min
The incidence of adverse effects of nausea. [Through Study Completion, an average of 1 day]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)