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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05518513
Other study ID # NCKUH-11109019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source National Cheng-Kung University Hospital
Contact Wei-Teng Weng, MD
Phone +886-6-2353535
Email n100390@mail.hosp.ncku.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date September 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacain
adductor canal block with 0.25% bupivacaine

Locations

Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Tria — View Citation

Jagannathan R, Niesen AD, D'Souza RS, Johnson RL. Intermittent bolus versus continuous infusion techniques for local anesthetic delivery in peripheral and truncal nerve analgesia: the current state of evidence. Reg Anesth Pain Med. 2019 Apr;44(4):447-451. — View Citation

Monahan AM, Sztain JF, Khatibi B, Furnish TJ, Jaeger P, Sessler DI, Mascha EJ, You J, Wen CH, Nakanote KA, Ilfeld BM. Continuous Adductor Canal Blocks: Does Varying Local Anesthetic Delivery Method (Automatic Repeated Bolus Doses Versus Continuous Basal I — View Citation

Thapa D, Ahuja V, Verma P, Gombar S, Gupta R, Dhiman D. Post-operative analgesia using intermittent vs. continuous adductor canal block technique: a randomized controlled trial. Acta Anaesthesiol Scand. 2016 Nov;60(10):1379-1385. doi: 10.1111/aas.12787. E — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Opioid related side effect Record if any sensation of urinary retention, skin pruritus In postoperative 2 days
Other Nerve block related complication Record if any episode of nerve block insertion site hematoma, leakage of local anesthetics, or local anesthetic systemic toxicity In postoperative 2 days
Primary Accumulated morphine consumption Additional morphine prescription In postoperative 48 hours
Secondary Numerical pain scale at rest 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
Secondary Numerical pain scale during knee flexion 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
Secondary Percentage of muscle power decrement 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
Secondary Postoperative nausea and vomiting Access if any sensation of nausea or episodes of vomiting In postoperative 2 days
Secondary Event of falling down Record the number of events of falling down In postoperative 2 days
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