Intravenous Lidocaine in Total Knee Replacement

NCT03597776 | Completed Phase 4 DMC

• 1 other identifier: UW18-276
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis of knees and hips is a common medical problem present in elderly, which poses significant impairment to their mobility, independence, and quality of life. Despite the availability of conservative treatment, such as simple analgesics and physiotherapy, total joint replacement is the only curative option for this disease entity. The latter, however, is not without risk. A study by Poulakka has demonstrated that patients with poor pain control in the postoperative period were three to ten times more likely to develop chronic pain, which may significantly impair the patients' functional status and quality of life. Optimal pain control is therefore essential in facilitating rehabilitation and in preventing long-term morbidities. Lidocaine \[2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide\] is an amide local anaesthetic that is characteristically fast in onset and short in duration of action. As such, it has long been used for providing regional anaesthesia for operation, but with limited role in terms of post operative analgesia. Recently, intravenous infusion of lidocaine has been shown to be safe and effective in reducing post operative pain (resting and dynamic), opioid consumption, and chronic post-surgical pain. The mechanism of action involves both peripheral and central actions. In addition to blockade of the Voltage-gated Sodium Channel of the peripheral nerves, lidocaine also inhibits priming of the PolyMorphoNuclear granulocyte (PMN) by inducing a time-dependent inhibition of intracellular G-protein signalling molecule (Gq); thus reducing release of cytokines and Reactive Oxygen Species Centrally, lidocaine also causes blockade of NMDA receptors and Neurokinin Receptors of the Wide-Dynamic Range Neurons in the dorsal horn of spinal cord; thus reduces glutamate activity. We therefore hypothesize that the use of intravenous lidocaine may reduce acute pain and improve the range of knee flexion after total knee replacement. Currently, there is strong evidence supporting its use in laparoscopic and open abdominal surgeries. There is, however, a paucity of studies in orthopedic surgeries. To date, there is no randomized controlled trial that studied its effect in total knee replacement.

Conditions

Acute Pain

Keywords

intravenous lidocaine; pain; total knee replacement; spinal 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 during movement and at rest, by NRS (movement) and NRS (rest) respectively

  at postoperative day 1

Secondary Outcomes (4)

• Range of motion (ROM) of knee

  until postoperative day 6

• Availability of usual activity of knee

  until postoperative day 6

• Self Care Assessment

  until postoperative day 6

• Side Effects of PCA Morphine

  until postoperative day 6

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

Bolus of intravenous lidocaine of 2mg/kg over 5 mins will be given before skin incision.

Drug: Lidocaine

Placebo Group

PLACEBO COMPARATOR

Normal Saline of 2mg/kg over 5 mins will be given as bolus before skin incision

Drug: Saline

Interventions

Lidocaine DRUG

Bolus of lidocaine will be given over 5 minutes before skin incision

Also known as: Lignocaine HCL inj 2% B.P.

Lidocaine Group

Saline DRUG

Bolus of saline will be given over 5 minutes before skin incision

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• Primary Elective Total Knee Replacement under Spinal Anaesthesia

You may not qualify if:

• Single Stage Bilateral Total Knee Replacement
• Revision Total Knee Replacement
• Contraindications to Spinal Anaesthesia or Failed Spinal Anaesthesia
• Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids
• Cardiac Disease: Any degree of Heart Block, Heart Failure
• Neurological: Any Seizure Disorder
• Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder
• Alcohol or substance abuse
• Chronic Pain, other than chronic knee pain
• Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
• Impaired Renal Function (defined as preoperative serum creatinine level over 200µmol/L)
• Impaired Hepatic Function
• Pregnancy
• Inability to use PCA
• Patient Refusal

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 24, 2018
• Study Start: January 3, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 14, 2020
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

HK (1)