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

April 17, 2023 updated by: Septian Adi Permana. MD, Universitas Sebelas Maret
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hs-CRP serum level
Time Frame: 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.
4 hours postoperative
hs-Troponin serum level
Time Frame: 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%
4 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full regression of sensory block
Time Frame: 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.
Through Study Completion, an average of 1 day
Duration of PACU (Post-Anaesthesia Care Unit) stay
Time Frame: 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

  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
Through Study Completion, an average of 1 day
Pain score after cystoscopy procedure
Time Frame: 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.
Through Study Completion, an average of 1 day
The incidence of adverse effects of hypotension
Time Frame: 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
Through Study Completion, an average of 1 day
The incidence of adverse effects of bradycardia
Time Frame: Through Study Completion, an average of 1 day
Bradycardia will be defined as heart rate < 50 beat/min
Through Study Completion, an average of 1 day
The incidence of adverse effects of nausea.
Time Frame: 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).
Through Study Completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sebelas Maret

Collaborators

Indonesia Endowment Fund for Education

Investigators

  • Principal Investigator: Purwoko Purwoko, PhD, Universitas Sebelas Maret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES/PR/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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