Total Knee Replacement TIVA With Robotic Arm Assisted

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.

Conditions

• Postoperative Pain

Interventions

DRUG

Propofol

Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Level of anaesthesia will be titrated to produce a BIS value of between 40-60. For induction, remifentanil 1mcg/kg and rocuronium 0.6 mg/kg will be given intravenously prior to intubation. Sevoflurane will not be given. Air and oxygen will be given, and FiO2 will be kept at between 35-50%. Similarly, to the GAS group, remifentanil will be infused at a rate of between 0.1-0.2mcg/kg/min and titrated according to the haemodynamic parameters stated for the GAS group. Morphine sulphate will be given at a dose of 0.1mg/kg before skin incision. TCI propofol and remifentanil will be switched off at the end of the procedure. Reversal of muscle relaxation will be achieved as for the GAS group.

DRUG

Sevoflurane

Patients in the GAS group will be induced with intravenous bolus propofol 1.5-3mg/kg, remifentanil 1mcg/kg, and rocuronium 0.6mg/kg for induction of general anaesthesia and intubation of patient. General anesthesia monitoring will be used. Maintenance of general anesthesia to be provided using sevoflurane, together with air and oxygen. FiO2 will be maintained between 35-50%. Bispectral (BIS) monitoring will be applied and level of anaesthesia will be maintained at a BIS value of 40-60. Remifentanil infusion will be given at between 0.1-0.2mcg/kg/min, to be titrated to maintain mean arterial blood pressure within 20% of baseline (blood pressure in ward before surgery as baseline) and heart rate between 45 to 100 bpm. Morphine sulphate to be given at a dose of 0.1mg/kg before skin incision. Sevoflurane and remifentanil infusion will be switched off at the end. Reversal of muscle relaxation to be achieved using intravenous neostigmine 50mcg/kg and atropine 20mcg/kg after the operation.

PROCEDURE

Spinal anaesthesia

Patients in the SA group will receive intrathecal (L4-5, or L3-4 if failed at L4-5) administration of 2.2-2.4ml 0.5% heavy bupivicaine using a 25G Whitacare needle. No intrathecal opioid will be given during the procedure. Light sedation will be given during surgery with target-controlled infusion of propofol using the Marsh effect site model (0.3 -1 mcg/ml). Supplemental oxygen 2L/min will be given via the nasal cannula.

Sponsors & Collaborators

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Stanley SC Wong, MBBS · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-22

Primary Completion

2023-12-31

Completion

2024-05-31

Countries

• Hong Kong

Study Locations