Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia

National University Health System (NUHS)

Status and phase: Active, not recruiting; Phase 4

Conditions: Knee Replacement, Total; Knee Replacement Surgery

Treatments: Drug: Bupivacaine; Drug: prilocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07329582

2023/00591

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

bupivacaine

Other group

Description:

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

Treatment:

Drug: prilocaine

prilocaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine