Continuous Infusion and Intermittent Bolus Adductor Canal Block for Total Knee Arthroplasty

April 4, 2024 updated by: Wei-Teng Weng, National Cheng-Kung University Hospital
The investigators believed the analgesic efficacy of adductor canal block on patients receiving total knee arthroplasty. However, the analgesic effects of different delivery regimens and duration of effects are variable. The investigators hypothesize that using continuous infusion and shorter interval bolus of local anesthetics to perform adductor canal block will reduce pain scale and opioid consumption in patients receiving total knee arthroplasty compared with longer interval bolus of local anesthetics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sensory innervations contributing pain after total knee arthroplasty (TKA) include branches of femoral, obturator and sciatic nerves. Branches of femoral nerve contribute the most pain sensation in TKA including nerves to the vastus medialis, intermedius, and lateralis, medial and intermediate femoral cutaneous, and saphenous nerves. Smaller contribution of pain sensation from branches of fibular and tibial nerves, and posterior branch of obturator nerve. Multiple techniques of nerve block could anesthetize some or all of the sensory innervations, but analgesia with motor sparing is important for early recovery and rehabilitation after TKA. For both pain reduction and motor function, adductor canal block (ACB) combined with local infiltration analgesia is considered more feasible than other peripheral nerve blocks.

ACB could anesthetize nerves beyond in adductor canal. Anatomical studies revealed the extended spreading of local anesthetics (LA) beyond adductor canal when performing ACB, and caudal spreading could reach popliteal fossa through adductor hiatus. Cephalad spreading of LA in ACB is limited and rarely extending to femoral triangle even when injecting from proximal adductor canal, but the cephalad spreading also depends on the volume of injectants and using tourniquets.

In clinical studies, both ACB injection site and volume of injectants were investigated. Clinical trials and systematic reviews revealed the similar efficacy of analgesia when ACB injection at proximal and distal adductor canal, although the volume and pattern of injection (bolus or continuous) were variable. Regarding to the volume of injectants, 20ml injectant of local anesthetics would be adequate without prominent motor impairment compared with smaller volume.

Previous systematic reviews and meta-analysis have confirmed better analgesia with continuous infusion of ACB than single shot, but few studies explored the difference of intermittent bolus and continuous infusion. One clinical trial compared continuous infusion and intermittent bolus of ACB in patients receiving TKA, two other trials investigated the difference in healthy volunteers and patients receiving knee arthroscopy. All these three studies concluded no difference of analgesic efficacy. However, no consistent volume and frequency of injection was studied. Whether longer interval of intermittent bolus was the same with continuous infusion in analgesic efficacy is still need to be further verified.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults receiving unilateral total knee arthroplasty under spinal anesthesia
  • American society of anesthesiologists 1-3

Exclusion Criteria:

  • Could not cooperate
  • Allergy to medicines used in the study
  • Chronic pain
  • Long term opioid use
  • Neuromuscular disease
  • Surgical complication: massive bleeding, postoperative ICU, unanticipated procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous infusion
adductor canal block with continuous infusion of 0.25% bupivacaine 3.5 ml per hour for 2 days postoperatively
Drug: Bupivacain
adductor canal block with 0.25% bupivacaine
Other Names:
  • Marcaine
Active Comparator: 12hrs intermittent bolus
adductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 12 hours for 2 days postoperatively
Drug: Bupivacain
adductor canal block with 0.25% bupivacaine
Other Names:
  • Marcaine
Experimental: 6hrs intermittent bolus
adductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 6 hours for 2 days postoperatively
Drug: Bupivacain
adductor canal block with 0.25% bupivacaine
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accumulated morphine consumption
Time Frame: In postoperative 48 hours
Additional morphine prescription
In postoperative 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical pain scale at rest
Time Frame: In postoperative 2 days
From no pain felt as 0 to the most pain felt as 10, measuring pain score at postoperative care unit, 3/9 pm on operative day, 9 am and 3/9 pm on postoperative day 1, 9 am and 3/9 pm on postoperative day 2
In postoperative 2 days
Numerical pain scale during knee flexion
Time Frame: In postoperative 2 days
From no pain felt as 0 to the most pain felt as 10, measuring pain score at postoperative care unit, 3/9 pm on operative day, 9 am and 3/9 pm on postoperative day 1, 9 am and 3/9 pm on postoperative day 2
In postoperative 2 days
Percentage of muscle power decrement
Time Frame: In postoperative 2 days
Extension strength of thigh at surgical side, measurement before surgery and postoperatively, access by dynameter as participants sit and perform surgical leg thigh extension, assessing at 9 am on postoperative day 1 and 2
In postoperative 2 days
Postoperative nausea and vomiting
Time Frame: In postoperative 2 days
Access if any sensation of nausea or episodes of vomiting
In postoperative 2 days
Event of falling down
Time Frame: In postoperative 2 days
Record the number of events of falling down
In postoperative 2 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid related side effect
Time Frame: In postoperative 2 days
Record if any sensation of urinary retention, skin pruritus
In postoperative 2 days
Nerve block related complication
Time Frame: In postoperative 2 days
Record if any episode of nerve block insertion site hematoma, leakage of local anesthetics, or local anesthetic systemic toxicity
In postoperative 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: WEI-TENG WENG, MD, Department of Anesthesiology, National Cheng Kung University Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKUH-11109019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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