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

NCT05834647 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-04-28

No results posted yet for this study

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

Interventions

DRUG

Prilocaine 2%

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

DRUG

Hyperbaric Lidocaine 5%

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

Sponsors & Collaborators

  • Indonesia Endowment Fund for Education

    collaborator UNKNOWN

  • Universitas Sebelas Maret

    lead OTHER

Principal Investigators

  • Purwoko Purwoko, PhD · Universitas Sebelas Maret

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-11-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05834647 on ClinicalTrials.gov