Knee Replacement, TotalPhase 4NCT07329582
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia
A Phase 4 study testing prilocaine and Bupivacaine in people with Knee Replacement, Total and Knee Replacement Surgery, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Knee Replacement, Total, Knee Replacement Surgery
- What is being tested?
- prilocaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 17 May 2024to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective unilateral total knee replacement
- Able to give informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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
- Knee Replacement, Total, Knee Replacement Surgery
- Being tested
- prilocaine, Bupivacaine
- Keywords
- total knee replacement, spinal anaesthesia, Bupivacaine, Prilocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prilocaineDrug
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
BupivacaineDrug
Bupivacaine has long been the go-to choice for spinal anesthesia in total knee replacement surgeries due to its effectiveness in providing surgical anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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.
Measured: From spinal anesthesia administration up to 24 hours post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start17 May 2024
- Primary completion1 Dec 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement, TotalStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to receive either prilocaine or bupivacaine for their spinal anesthesia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmin Jeanette Tan, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329582
- Sponsor's protocol ID
- 2023/00591
- Other IDs
- 2023
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07329582
- Acronym / sponsor ID
- 2023/00591
- Conditions
- Knee Replacement, Total, Knee Replacement Surgery
- Keywords
- total knee replacement, spinal anaesthesia, Bupivacaine, Prilocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to receive either prilocaine or bupivacaine for their spinal anesthesia
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Other | Drug: prilocaineThe 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 |
| prilocaine | Active comparator | Drug: BupivacaineThe 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 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing elective unilateral total knee replacement
- Able to give informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prilocainePrilocaine 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 | Drug | bupivacaine |
| BupivacaineBupivacaine has long been the go-to choice for spinal anesthesia in total knee replacement surgeries due to its effectiveness in providing surgical anesthesia | Drug | prilocaine |
Primary outcome
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.
1 secondary outcome
Comparison of Side Effects between Prilocaine and Bupivacaine
Time frame: From spinal anesthesia administration up to 24 hours post-operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmin Jeanette Tan principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prilocaine and Bupivacaine in people with Knee Replacement, Total and Knee Replacement Surgery, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Motor Block (time frame: Measured from the time of spinal anesthesia administration until full motor recovery, expected within 24 hours post-operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.