NCT06054945

Brief Summary

In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block to this regimen, and the aim of this retrospective study is to determine whether the addition of the IPACK block enhances the quality of analgesia. Knee arthroplasty, also known as knee joint replacement surgery, is a common procedure performed to alleviate pain and improve joint function in patients with knee osteoarthritis or other knee-related conditions. Postoperative pain management is crucial for patient comfort and overall recovery. In this study, we aimed to compare the two techniques mentioned earlier, namely the SIFIB (Suprainguinal Fascia Iliaca Block) and the SIFIB+IPACK, by examining the data of patients who underwent knee arthroplasty under spinal anesthesia at our clinic between January 1, 2023, and September 1, 2023.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 3, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

12 days

First QC Date

September 15, 2023

Last Update Submit

September 27, 2023

Conditions

Keywords

analgesiaIPACKSIFIB

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Opioid consumption via PCA device

    24 hours

Secondary Outcomes (1)

  • NRS scores

    24 hours

Study Arms (2)

SIFIB

Patients who underwent SIFIB in knee arthroplasty patients under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores.

Procedure: SIFIB (suprainguinal fascia iliaca block)Device: Patient controlled anagesia device

SIFIB+IPACK

Patients who underwent SIFIB+IPACK blocks in knee arthroplasty patients under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores.

Procedure: SIFIB (suprainguinal fascia iliaca block)Other: IPACK (Interspace between the popliteal artery and capsule of the posterior knee )Device: Patient controlled anagesia device

Interventions

Ultrasound guided Suprainguinal Fascia Iliaca Block for Knee Arthroplasty Patients

SIFIBSIFIB+IPACK

Ultrasound guided IPACK (Interspace between the popliteal artery and capsule of the posterior knee ) Block for Knee Arthroplasty Patients

SIFIB+IPACK

Those who were administered opioids with PCA as rescue analgesic in the postoperative analgesia plan on the selected dates will be included in the study.

Also known as: PCA
SIFIBSIFIB+IPACK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

data of patients underwent total knee arthroplasty under spinal anesthesia between 01.01.2023 and 01.09.2023

You may qualify if:

  • Patients meeting the following criteria and whose postoperative follow-up forms were completed in full were included in the study
  • Patients underwent total knee arthroplasty (TKA)
  • ASA class I to III.
  • operated under spinal anesthesia
  • patient controlled analjgesia device was used for analgesia

You may not qualify if:

  • Patients whose data were inaccessible or had incomplete follow-up forms were excluded from the study to ensure the accuracy and reliability of our analysis.
  • PCA device problems in follow up in 24 hours
  • anesthesia plans were converted to general anesthesia
  • spinal anesthesia failure
  • peripheral blocks used other than protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaAcute Pain

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Officials

  • Hatice Kusderci, M.D.

    Samsun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 26, 2023

Study Start

September 3, 2023

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations