Total Knee Replacement TIVA With Robotic Arm Assisted

NCT04002271 | Unknown Phase 4

• 1 other identifier: UW19-282
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

TIVA; total knee replacement; post operative pain; acute pain; anaesthesia

Outcome Measures

Primary Outcomes (1)

• Pain assessed by numerical rating scales (NRS) pain scores

  NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded at rest and with movement everyday.

  from postoperative day 0 until postoperative day 4

Secondary Outcomes (6)

• PCA morphine consumption

  from postoperative day 0 until postoperative day 5

• Dihydrocodeine use

  from postoperative day 0 until postoperative day 5

• Side effects of analgesics

  from postoperative day 0 until postoperative day 5

• Range of motion (ROM) of knee

  until postoperative day 6

• Overall benefit of analgesic scores (OBAS)

  from postoperative day 0 to postoperative day 5 on phone

Study Arms (3)

Group SA

ACTIVE COMPARATOR

Patients in Group SA will undergo spinal anaesthesia.

Procedure: Spinal anaesthesia

Group GAS

ACTIVE COMPARATOR

Patients in Group GAS will undergo general inhalational anaesthesia using sevoflurane.

Drug: Sevoflurane

Group TIVA

EXPERIMENTAL

Patients in Group TIVA will undergo general anaesthesia using propofol total intravenous anaesthesia.

Drug: Propofol

Interventions

Propofol DRUG

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.

Group TIVA

Sevoflurane DRUG

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.

Group GAS

Spinal anaesthesia PROCEDURE

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.

Group SA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Propofol; Sevoflurane; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Stanley SC Wong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley SC Wong, MBBS

CONTACT

(852)22553303; wongstan@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This is an observer blinded randomized controlled trial. The patients will be aware of whether they received spinal anaesthesia (SA) or general anaesthesia (TIVA or GAS). The investigators responsible for assessing outcomes and collecting data will be blinded to patient allocation. The anaesthetist performing anaesthesia will be aware of patient allocation, but will not be involved in data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients in group SA will undergo spinal anaesthesia. Patients in group GAS will undergo general inhalational anaesthesia using sevoflurane. Patients in group TIVA will undergo general anaesthesia using propofol total intravenous anaesthesia

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: July 22, 2020
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

HK (2)