Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia

NCT07329582 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2023/00591
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Replacement, Total; Knee Replacement Surgery

Keywords

total knee replacement; spinal anaesthesia; Bupivacaine; Prilocaine

Outcome Measures

Primary Outcomes (1)

• Duration of Motor Block

  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.

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

Secondary Outcomes (1)

• Comparison of Side Effects between Prilocaine and Bupivacaine

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

Study Arms (2)

bupivacaine

OTHER

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

Drug: prilocaine

prilocaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

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

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

prilocaine

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital Singapore

Singapore, 119074, Singapore

Location

MeSH Terms

Interventions

Prilocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jasmin Jeanette Tan

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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."
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 9, 2026
• Study Start: May 17, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)