Total Knee Replacement TIVA With Robotic Arm Assisted

• Status: Not yet recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Total knee replacement (TKR) is a commonly performed surgical procedure, and is associated with moderate to severe acute postoperative pain. Poor acute postoperative pain control has been associated with increased morbidity, prolonged recovery, reduced patient satisfaction and chronic post-surgical pain. Multimodal analgesia in the context of enhanced recovery after surgery programs is advocated for conventional total knee replacement. More recently, robotic arm assisted total knee replacement has been introduced. TKR is most commonly performed under spinal anaesthesia or general anaesthesia using inhalational agents or propofol total intravenous anaesthesia (TIVA). It is unclear which is the best anaesthetic technique for postoperative analgesia. There has been no head to head trial comparing these 3 anaesthetic techniques in the context of modern multimodal and enhanced recovery after surgery (ERAS) protocols for conventional and robotic arm assisted TKR. Propofol TIVA may reduce postoperative pain and opioid consumption after surgery, but the overall evidence is still controversial. Whether propofol TIVA provides better analgesia compared to inhalational anaesthesia for TKR is not known. A prospective, randomized controlled trial providing head to head comparisons between general anaesthesia with propofol TIVA, inhalational anaesthesia, and spinal anaesthesia under is indicated.

In this study, we plan to perform a randomized controlled trial to compare postoperative analgesia after robotic arm assisted TKR in three commonly used anaesthetic techniques: 1) spinal anaesthesia (SA), 2) general anaesthesia with inhalational anaesthesia (GAS), 3) general anaesthesia with propofol TIVA (TIVA). This clinical trial will be conducted within the framework of modern multimodal analgesic and enhanced recovery after surgery pathways.

In this study, we plan to perform a randomized controlled trial to compare postoperative analgesia after TKR in three commonly used anaesthetic techniques: 1) spinal anaesthesia (SA), 2) general anaesthesia with inhalational anaesthesia (GAS), 3) general anaesthesia with propofol TIVA (TIVA). This clinical trial will be conducted within the framework of modern multimodal analgesic and enhanced recovery after surgery pathways.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Anesthetics; Propofol; Sevoflurane

Criteria

Inclusion Criteria:

• ASA I-III

• Scheduled for elective primary unilateral total knee replacement

• Able to speak and understand Chinese (including Cantonese and Mandarin)

• Able to provide informed consent

Exclusion Criteria:

• Revision total knee replacement

• Single stage bilateral total knee replacement

• Previous major knee surgery to the same knee

• Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors

• History of chronic pain other than chronic knee pain

• Rheumatoid arthritis

• Immunological depression

• Chronic opioid user

• Alcohol or drug abuse

• Obesity (Body mass index over 35kg/m2)

• Impaired liver function (Plasma bilirubin over 34 μmol/L, INR ≥ 1.7, ALT and AST over 100U/L)

• Impaired renal function, defined as preoperative serum creatinine level over 120 μmol/L

• Pre-existing neurological or muscular disorders

• Psychiatric or neurological disease that could potentially influencing pain perception

• Impaired or retarded mental state

• Difficulties in using patient controlled analgesia (PCA)

• Pregnancy

• Local infection

• Patient refusal

• Strong preference for a particular type of anaesthesia