Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-17

Study Completion Date

2026-06-30

Brief Summary

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Prilocaine numbs you for a shorter time, allowing you to regain movement quicker, which helps you recover faster, start rehab sooner, and feel more satisfied with your treatment overall.

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Detailed Description

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Bupivacaine has long been the go-to choice for spinal anesthesia in total knee replacement surgeries due to its effectiveness in providing surgical anesthesia. However, it comes with some drawbacks, primarily its prolonged motor block and the potential for dose-related hypotension, which can hinder post-operative recovery. In contrast, prilocaine has gained popularity in recent years, particularly for outpatient procedures and even caesarean sections. Prilocaine's appeal lies in its faster recovery profile, characterized by a shorter duration of motor block and reduced incidence of urinary retention. These properties make it an attractive option for total knee replacement patients, as it potentially allows for quicker rehabilitation. The shorter-acting nature of prilocaine means patients may regain mobility sooner, potentially leading to earlier discharge and improved overall satisfaction. Despite these promising attributes, there's a notable gap in research comparing the intrathecal use of hyperbaric prilocaine 2% with hyperbaric bupivacaine 0.5%, especially within the Asian population. This lack of comparative studies highlights the need for further investigation to determine if prilocaine's benefits observed in other contexts translate effectively to total knee replacement procedures in Asian patients, potentially offering a pathway to enhanced recovery protocols in this specific demographic.

Conditions

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Knee Replacement, Total Knee Replacement Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to receive either prilocaine or bupivacaine for their spinal anesthesia

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This helps to eliminate potential placebo effects or bias in self-reported outcomes. The masking of outcome assessors ensures that the individuals evaluating the results of the trial are unaware of which treatment each participant received. By masking both participants and outcome assessors, the study aims to minimize bias and increase the reliability of the results, as neither the subjects nor those evaluating their progress can be influenced by knowledge of the treatment assignment."

Study Groups

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bupivacaine

The administration of the spinal anesthetic will follow the hospital's standard protocol for this procedure. This means that apart from the specific local anesthetic used (prilocaine or bupivacaine), all other aspects of the anesthesia process - including patient preparation, sterile technique, needle size and type, patient positioning, and post-procedure care - will remain consistent with the hospital's established guidelines for spinal anesthesia

Group Type OTHER

prilocaine

Intervention Type DRUG

Prilocaine is known to have a faster recovery time by producing a shorter duration of motor block and less urinary retention, this results in a more rapid rehabilitation in post-total knee replacement surgical patients

prilocaine

The administration of the spinal anesthetic will follow the hospital's standard protocol for this procedure. This means that apart from the specific local anesthetic used (prilocaine or bupivacaine), all other aspects of the anesthesia process - including patient preparation, sterile technique, needle size and type, patient positioning, and post-procedure care - will remain consistent with the hospital's established guidelines for spinal anesthesia

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivacaine has long been the go-to choice for spinal anesthesia in total knee replacement surgeries due to its effectiveness in providing surgical anesthesia

Interventions

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prilocaine

Prilocaine is known to have a faster recovery time by producing a shorter duration of motor block and less urinary retention, this results in a more rapid rehabilitation in post-total knee replacement surgical patients

Intervention Type DRUG

Bupivacaine

Bupivacaine has long been the go-to choice for spinal anesthesia in total knee replacement surgeries due to its effectiveness in providing surgical anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* undergoing elective unilateral total knee replacement
* Able to give informed consent

Exclusion Criteria

* Patients of age \< 21 or \> 90 years old
* American Society of Anaesthesiologists (ASA) physical status\> III
* Extremes of weight: \<40kg or BMI \>40
* Contra-indications to spinal anaesthesia, prilocaine or bupivacaine (including allergy to local anaesthesia agents or patients at high risk for methaemoglobinemia)
* Complex TKR as deemed by surgeons
* Patient refusal
* Failure of spinal anaesthesia resulting in conversion to general anaesthesia, prior to start of operation
* Patients with prostate hyperplasia or urogenital pathologies
* Planning to conceive / pregnant women / breastfeeding

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No