NCT03597776

Intravenous Lidocaine in Total Knee Replacement

Completed Phase 4 Last updated 16 May 2024

What this trial tests

Phase 4 trial testing Lidocaine in Acute Pain in 62 participants. Completed in 14 September 2020.

Timeline

3 January 2019

Primary endpoint
10 September 2020

14 September 2020

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	62
Start date	3 January 2019
Primary completion	10 September 2020
Estimated completion	14 September 2020
Sites	1 location across Hong Kong

Drugs / interventions tested

• Lidocaine — full drug profile →
• Saline

Conditions studied

• Acute Pain — all drugs for Acute Pain →

Sponsor

The University of Hong Kong

Who can join

Adults 18 to 80, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.