NCT05505890

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

August 15, 2022

Last Update Submit

February 21, 2023

Conditions

Keywords

bupivacaine, myotoxicity, creatine phosphokinase,SFIPB

Outcome Measures

Primary Outcomes (1)

  • CPK levels

    Change from Baseline serum creatine phosphokinase at 24 hours

    at postoperative 24th hour

Secondary Outcomes (1)

  • Number of patients requesting rescue analgesics

    up to 24 hours

Study Arms (2)

SFIPB

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

Other: suprainguinal fascia iliaca block

control

Fascia iliac block will not be applied to this group. Postoperative analgesia will be provided with other analgesia modalities.

Interventions

Suprainguinal fascia iliaca block will be performed after the end of surgery for postoperative analgesia.

SFIPB

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

Location

Related Publications (1)

  • Rakhi V, Kaushal S, Singh S. Measurement of bupivacaine induced myotoxicity in interfascial plane blocks: A randomised controlled trial. Indian J Anaesth. 2021 Dec;65(12):886-891. doi: 10.4103/ija.ija_848_21. Epub 2021 Dec 22.

MeSH Terms

Conditions

Myotoxicity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Officials

  • Serkan Tulgar

    Samsun University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 18, 2022

Study Start

December 16, 2022

Primary Completion

February 21, 2023

Study Completion

February 21, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations