NCT04931966

Brief Summary

105 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=35), where an adductor canal block, group B (N:35) where an adductor canal block with IPCAK, and group C (n=35) where an adductor canal block with PAI will be performed preoperatively. All patients will receive a standardized multimodal approach. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 9, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

June 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

June 9, 2021

Last Update Submit

August 17, 2021

Conditions

Osteo Arthritis Knee

Keywords

Total knee arthroplastyPeri articular infiltrationIpack blockAdductor canal block

Outcome Measures

Primary Outcomes (1)

  • NRS scores

    Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)

    48 hours

Secondary Outcomes (7)

  • Opioid consumption

    4-6-8-12-24 and 48 hours

  • Range of knee motion

    48 hours

  • Complications

    48 hours

  • Patient satisfaction

    48 hours

  • Incidence of adverse events related to nerve block procedures

    Post-op 24 to 72 hours

  • +2 more secondary outcomes

Study Arms (3)

Group A

ACTIVE COMPARATOR

Adductor canal block

Procedure: blockProcedure: adductor canal block

Group B

ACTIVE COMPARATOR

Adductor canal block plus IPACK

Procedure: blockProcedure: adductor canal blockProcedure: Adductor Canal Block plus IPACK Block

Group C

ACTIVE COMPARATOR

Adductor canal block plus PAI

Procedure: blockProcedure: adductor canal blockProcedure: adductor Canal Block plus PAI Block

Interventions

blockPROCEDURE

Adductor canal block

Group AGroup BGroup C
adductor canal blockPROCEDURE

adductor canal block bupivacain

Group AGroup BGroup C
Adductor Canal Block plus IPACK BlockPROCEDURE

Adductor Canal Block plus IPACK Block using bupivacaine

Group B
adductor Canal Block plus PAI BlockPROCEDURE

Adductor Canal Block plus PAI Block using bupivacaine

Group C

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical status according to American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for total knee arthroplasty

You may not qualify if:

  • Previous operation on same knee
  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 85
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • BMI \> 40
  • ASA IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (2)

  • Kertkiatkachorn W, Kampitak W, Tanavalee A, Ngarmukos S. Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. J Arthroplasty. 2021 Jan;36(1):122-129.e1. doi: 10.1016/j.arth.2020.06.086. Epub 2020 Jul 2.

    PMID: 32694032BACKGROUND

  • Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.

    PMID: 30234517BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 18, 2021

Study Start

June 22, 2021

Primary Completion

August 8, 2021

Study Completion

August 17, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)