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NCT Number: NCT07329582

Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Replacement, Total Knee Replacement Surgery

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National University Hospital Singapore

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prilocaine

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

Bupivacaine

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

Primary outcomes

  1. Duration of Motor Block

    Time frame: Measured from the time of spinal anesthesia administration until full motor recovery, expected within 24 hours post-operation.

    This study will measure the duration of motor block, defined as the time from spinal anesthesia administration to full recovery of motor function. Motor function will be assessed using the modified Bromage scale, with full recovery defined as a Bromage score of 0 (full movement of legs and feet). The primary hypothesis is that prilocaine will produce an effective sensory block while resulting in a significantly shorter duration of motor block compared to bupivacaine. Assessments will be conducted at regular intervals following the administration of spinal anesthesia until full motor recovery is achieved, with an expected timeframe of up to 24 hours post-operation. This outcome measure will help determine the comparative efficacy of prilocaine versus bupivacaine in facilitating earlier mobilization and potentially enhancing post-operative recovery in patients undergoing total knee replacement surgery.

Secondary outcomes

  1. Comparison of Side Effects between Prilocaine and Bupivacaine

    Time frame: From spinal anesthesia administration up to 24 hours post-operation.

    The study will assess the overall incidence and severity of anesthesia-related adverse events associated with intrathecal prilocaine and bupivacaine in patients undergoing total knee replacement surgery. The measure encompasses a comprehensive range of potential physiological, neurological, and systemic reactions typically associated with spinal anesthesia and local anesthetic use.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

A Prospective, Double-blinded, Randomised Controlled Trial Comparing the Use of Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine for Spinal Anaesthesia in Asian Patients Undergoing Elective Total Knee Replacement

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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