Observation Study of the Pharmacokinetics of Adductor Canal Block

With the aging of the population, osteoarthritis of knees and hips become major orthopedic problems worldwide. Osteoarthritis of the knees and hips is associated with a significant pain problem and functional disability. Total joints replacement is the ultimate surgical procedure to deal with such problems. Multimodal analgesia, including periarticular local infiltration of analgesia (LIA), regional nerve block using adductor canal block (ACB), opioid and non-opioid have been shown to be effective in managing postoperative pain. Regional nerve block using femoral nerve block or adductor canal block (ACB) is also a well-established analgesic technique after total knee replacement. Standard bupivacaine (SB), levobupivacaine, ropivacaine were used in ACB in these studies. Whether combining ACB with periarticular LIA has the additional benefit of prolonging analgesia or with synergistic effect remains controversial, because the number of RCTs conducted is not enough. Liposomal bupivacaine (LB) may further prolong the analgesic effect of ACB, as the therapeutic levels of bupivacaine are below the toxic range and sustained for 72 hours after injection. The purpose of this study is to evaluate the safety and systemic levels of serum bupivacaine following adductor canal block using LB 66.5mg in patients undergoing TKA with LIA over a 72-hour period. This also serves as a pilot study to determine the dose and timing of blood taking for serum bupivacaine level of a previously IRB approved study - "Comparing the efficacy of combining periarticular local infiltration of analgesia and adductor canal block using liposomal bupivacaine and standard bupivacaine- A prospective randomized controlled trial".

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Key information

Conditions

Toxicity, Drug Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong

About this study

After signing the consent form, participants will receive LIA with ACB using 5ml of 1.33% liposomal bupivacaine with 5ml of 0.9% normal saline.

Participants will receive routine preoperative, intraoperative, and postoperative treatments like other patients undergoing total knee replacement.

Blood will be collected during induction, at 1 hour, 2 hours, 4 hours, 8 hours, and 12 hours after the performance of ACB through a designated 14-gauge cannula, and also at 24, 48, and 72 hours after the operation during routine blood taking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ASA I-III
Age 18-80 years old
Scheduled for elective primary unilateral total knee replacement
Chinese patients
BMI < 40
Able to speak and understand Cantonese
Able to provide informed oral and written consent

Exclusion criteria

Single-stage bilateral total knee replacement
Complex primary total knee replacement requiring the use of stem/augment/constrained liner
Surgeries with significant intraoperative complications which may alter rehabilitation protocol e.g. collateral ligament injury, fracture requiring fixation
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
History of immunosuppression
Daily use of glucocorticoids
Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
History of severe heart disease (NYHA 2)
Alcohol or drug abuse
Impaired renal function, defined as preoperative serum creatinine level over 120 micromol/L
Pre-existing neurological or muscular disorders
Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
Impaired or retarded mental state
Difficulties in using patient-controlled analgesia (PCA)
Pregnancy
Local infection
On immunosuppressants
High BMI (>=40)
Patient refusal

Treatment and study plan

Liposomal bupivacaine

Drug

5ml of 1.33% liposomal bupivacaine with 5 ml of 0.9% normal saline will be given to treatment group.

Primary outcomes

Time to peak concentration of serum bupivacaine

Time frame: 72 hours after the operation

Serum bupivacaine will be quantified using High Performance Liquid Chromatography.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

An Observational Study of the Pharmacokinetics of Adductor Canal Block Using Liposomal Bupivacaine and Standard Bupivacaine in Total Knee Arthroplasty Patients

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Jun 7, 2021
Registry last updated: Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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