NCT06498557

Brief Summary

Postoperative analgesic treatment methods are applied to patients who have undergone knee arthroplasty. These applications are a routine part of the procedure. It is medically and ethically necessary. Postoperative analgesia applications are started during the intraoperative period and continued during the postoperative period. The analgesia protocol to be used is shaped by the characteristics of the patient and the skill and experience of the anesthesiologist. The scientifically accepted method is multimodel analgesia protocols. These protocols cover a wide range from paracetamol to opioids to peripheral and central blocks (methods such as suprainguinal fascia iliac block (SFIP), adductor block (ACB) and infiltration analgesia (IPACK) applied between the posterior elements of the knee and the popliteal artery). Our aim in this study is to evaluate the effects of analgesia protocols applied to patients undergoing knee arthroplasty surgery on inflammatory biomarkers (such as neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), systemic immune inflammation score (SII), lactate) obtained from routine blood and blood gas examinations in the first 24 hours of the postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
Last Updated

November 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 29, 2024

Last Update Submit

November 21, 2024

Conditions

Keywords

POSTOPERATIVE PAINKnee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively.

    postoperative 24 hours

Secondary Outcomes (4)

  • inflammatory mediators

    preoperative 24 hours

  • inflammatory mediators

    preoperative 24 hours

  • inflammatory mediators

    preoperative 24 hours

  • inflammatory mediators

    preoperative 24 hours

Study Arms (2)

Group S

SFIP block will be applied for postoperative analgesic purposes

Other: Peripheral nerve block methods

Group IP

SFIP block will be applied for postoperative analgesic purposes

Other: Peripheral nerve block methods

Interventions

We apply different nerve blocks to patients for analgesic purposes after knee replacement surgery. These blocks are a combination of SFIP block and adductor channel block and iPACK block.

Group IPGroup S

Eligibility Criteria

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

Among patients who had elective knee replacement surgery, those who underwent postoperative nerve block

You may qualify if:

  • years old
  • ASA I,II,III patients
  • Patients who will undergo elective surgery

You may not qualify if:

  • Patients undergoing emergency surgery
  • Patients with bleeding diathesis
  • Those who are allergic or sensitive to local anesthetics and opioid drugs,
  • Those who use gabapentinoids
  • Patients with neurocognitive disorders,
  • Patients with chronic organ failure,
  • Mothers with suspected pregnancy, pregnant or breastfeeding mothers
  • Patients using opioids
  • Those who use steroids
  • Those with a history of substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAMSUN UNIVERSITY Samsun Training and research hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Senay canikli adıgüzel

    Samsun University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 12, 2024

Study Start

July 22, 2024

Primary Completion

October 4, 2024

Study Completion

October 5, 2024

Last Updated

November 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Participants' data will not be shared. After the study is written as an article, it can be shared if the editor of the journal wishes

Locations