- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06508177
CPK Levels After LC and Association With Analgesic Modalities
June 18, 2025 updated by: Samsun University
Does Postoperative Analgesic Modalities Effect Blood Creatin Phosphokinase Levels After Laparoscopic Cholecystectomy Surgery?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
During 3 months period all elligible patients undergoing laparoscopic cholecystectomy 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 creatin phosphokinase (CPK) levels will be tested 3 times of all patients(preoperative, postoperative 6th hour, postoperative 24th hour).
Data will be analysed and patients will be grouped according to the analgesic modalities used.
Study Type
Observational
Enrollment (Actual)
80
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
-
-
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Samsun, Turkey
- Samsun University
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients who underwent laparoscopic cholecystectomy ASA 1-3.
age:18-70
Description
Inclusion Criteria:
- ASA 1-3
- Laparoscopic cholecystectomy
- under General Anesthesia
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Interfascial plane blocks will be added to the routine analgesia plan as part of multimodal analgesia.
This is the routine analgesia plan applied in our clinic.
|
|
Control
Multimodal analgesia plans that does not include interfascial plane blocks
|
This is the routine analgesia plan applied in our clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPK levels
Time Frame: at postoperative 24th hour
|
Serum creatine phosphokinase levels at 24th hour
|
at postoperative 24th hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
August 5, 2024
Primary Completion (Actual)
March 30, 2025
Study Completion (Actual)
March 30, 2025
Study Registration Dates
First Submitted
July 12, 2024
First Submitted That Met QC Criteria
July 12, 2024
First Posted (Actual)
July 18, 2024
Study Record Updates
Last Update Posted (Actual)
June 24, 2025
Last Update Submitted That Met QC Criteria
June 18, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SamsunU_LapCholecyst_CK
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.
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