NCT05518513

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

August 21, 2022

Last Update Submit

April 4, 2024

Conditions

Keywords

total knee arthroplastyadductor canal blocknerve blockregional analgesia

Outcome Measures

Primary Outcomes (1)

  • Accumulated morphine consumption

    Additional morphine prescription

    In postoperative 48 hours

Secondary Outcomes (5)

  • Numerical pain scale at rest

    In postoperative 2 days

  • Numerical pain scale during knee flexion

    In postoperative 2 days

  • Percentage of muscle power decrement

    In postoperative 2 days

  • Postoperative nausea and vomiting

    In postoperative 2 days

  • Event of falling down

    In postoperative 2 days

Other Outcomes (2)

  • Opioid related side effect

    In postoperative 2 days

  • Nerve block related complication

    In postoperative 2 days

Study Arms (3)

Continuous infusion

EXPERIMENTAL

adductor canal block with continuous infusion of 0.25% bupivacaine 3.5 ml per hour for 2 days postoperatively

Drug: Bupivacain

12hrs intermittent bolus

ACTIVE COMPARATOR

adductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 12 hours for 2 days postoperatively

Drug: Bupivacain

6hrs intermittent bolus

EXPERIMENTAL

adductor canal block with intermittent bolus of 0.25% bupivacaine 21 ml every 6 hours for 2 days postoperatively

Drug: Bupivacain

Interventions

adductor canal block with 0.25% bupivacaine

Also known as: Marcaine
12hrs intermittent bolus6hrs intermittent bolusContinuous infusion

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Related Publications (4)

  • 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 Infusion) Influence Cutaneous Analgesia and Quadriceps Femoris Strength? A Randomized, Double-Masked, Controlled, Split-Body Volunteer Study. Anesth Analg. 2016 May;122(5):1681-8. doi: 10.1213/ANE.0000000000001182.

  • 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. Epub 2016 Sep 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 Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.

  • 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. doi: 10.1136/rapm-2018-100082. Epub 2019 Feb 3.

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • WEI-TENG WENG, MD

    Department of Anesthesiology, National Cheng Kung University Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician of Anesthesiology

Study Record Dates

First Submitted

August 21, 2022

First Posted

August 26, 2022

Study Start

November 1, 2022

Primary Completion

June 30, 2024

Study Completion

September 30, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations