Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty

February 21, 2023 updated by: Samsun University
Regional anesthesia and analgesia technics are widely and securely used during orthopedic surgery. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. We aimed to examine plasma CPK(creatine phosphokinase) levels to see whether myotoxicity occurs or not after suprainguinal fascial plane block is applied to patients undergoing knee artroplasty surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During 2 months period all elligible patients undergoing knee artoplasty surgery will be included in the study. Different postoperative analgesic modalities will be used according to the anesthesists experience. During routine blood sample tests plasma CPK levels will be tested 3 times of all patients.(preoperative, postoperative 6th hour, postoperative 24th hour) this data will be recorded for 2 months. After this period of time data will be analysed and patients will be grouped according to the analgesic modalities used.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey
        • Samsun University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing knee artroplasty surgery of ASA status 1-3. aged between 18-75years.

Description

Inclusion Criteria:

  • ASA 1-3
  • knee artoplasty patients
  • under spinal anesthesia

Exclusion Criteria:

  • local anesthetic allergies
  • myopathies
  • coagulopathies
  • Obstructive sleep apne syndrome
  • hearth diseases
  • liver diseases
  • kidney diseases
  • thyroid-parathyriod dieseas
  • hiperlipidemias using Statins(HMG-CoA reductase inhibitors)
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SFIPB

suprainguinal fascia iliaca plane block with 50ml of %0.25 bupivacaine will be used for postoperative analgesia

.
Other: suprainguinal fascia iliaca block
Suprainguinal fascia iliaca block will be performed after the end of surgery for postoperative analgesia.
control
Fascia iliac block will not be applied to this group. Postoperative analgesia will be provided with other analgesia modalities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPK levels
Time Frame: at postoperative 24th hour
Change from Baseline serum creatine phosphokinase at 24 hours
at postoperative 24th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients requesting rescue analgesics
Time Frame: up to 24 hours
Intravenous administration of meperidine 25 mg as a rescue analgesic is planned for patients who complain of severe pain despite multimodal analgesia.
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Investigators

  • Study Chair: Serkan Tulgar, Samsun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Actual)

February 21, 2023

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SamsunU_SFIPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myotoxicity

Clinical Trials on suprainguinal fascia iliaca block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe