NCT06508177

Brief Summary

Regional anesthesia and analgesia technics are widely and securely used during general surgery procedures. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. The investigators aimed to examine plasma creatine phosphokinase (CPK) levels to see whether myotoxicity occurs or not after fascial plane blocks are applied to patients undergoing laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

August 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

July 12, 2024

Last Update Submit

June 18, 2025

Conditions

Keywords

creatine phosphokinasecholecystectomyinterfascial plane blocks

Outcome Measures

Primary Outcomes (1)

  • CPK levels

    Serum creatine phosphokinase levels at 24th hour

    at postoperative 24th hour

Study Arms (2)

Interfascial plane blocks

Patients who are preferred to apply interfascial plane blocks as part of multimodal analgesia in the postoperative analgesia plan will be evaluated in this group.

Other: İnterfascial plane blockOther: Standart analgesia plan

Control

Multimodal analgesia plans that does not include interfascial plane blocks

Other: Standart analgesia plan

Interventions

Interfascial plane blocks will be added to the routine analgesia plan as part of multimodal analgesia.

Interfascial plane blocks

This is the routine analgesia plan applied in our clinic.

ControlInterfascial plane blocks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent laparoscopic cholecystectomy ASA 1-3. age:18-70

You may qualify if:

  • ASA 1-3
  • Laparoscopic cholecystectomy
  • under General Anesthesia

You may not qualify if:

  • Morbidly obesity or cachexia
  • 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.

    PMID: 35221361BACKGROUND

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

July 12, 2024

First Posted

July 18, 2024

Study Start

August 5, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations