MyotoxicityNCT06508177
CPK Levels After LC and Association With Analgesic Modalities
An observational study of Myotoxicity, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myotoxicity
- What is being tested?
- İnterfascial plane block and Standart analgesia plan
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent laparoscopic cholecystectomy ASA 1-3. age:18-70
Who may be able to join
- ASA 1-3
- Laparoscopic cholecystectomy
- under General Anesthesia
Who cannot join
- Morbidly obesity or cachexia
- local anesthetic allergies
- myopathies
- coagulopathies
- Obstructive sleep apne syndrome
- hearth diseases
Show all 11Show fewer
- liver diseases
- kidney diseases
- thyroid-parathyriod dieseas
- hiperlipidemias using Statins(HMG-CoA reductase inhibitors)
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myotoxicity
- Being tested
- İnterfascial plane block, Standart analgesia plan
- Keywords
- creatine phosphokinase, cholecystectomy, interfascial plane blocks
- Medical subject headings
- Myotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İnterfascial plane blockOther
Interfascial plane blocks will be added to the routine analgesia plan as part of multimodal analgesia.
Standart analgesia planOther
This is the routine analgesia plan applied in our clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: İnterfascial plane block; Other: Standart analgesia plan | |
| Control | Multimodal analgesia plans that does not include interfascial plane blocks Receives: Other: Standart analgesia plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPK levels
Serum creatine phosphokinase levels at 24th hour
Measured: at postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start5 Aug 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serkan Tulgar, Study chair, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508177
- Sponsor's protocol ID
- SamsunU_LapCholecyst_CK
- Status last verified
- Jun 2025
- First submitted
- 12 Jul 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35221361
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Postoperative Analgesic Modalities Effect Blood Creatin Phosphokinase Levels After Laparoscopic Cholecystectomy Surgery?
- ClinicalTrials.gov ID
- NCT06508177
- Acronym / sponsor ID
- SamsunU_LapCholecyst_CK
- Conditions
- Myotoxicity
- Keywords
- creatine phosphokinase, cholecystectomy, interfascial plane blocks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interfascial plane blocks | – | Other: İnterfascial plane block, Other: Standart analgesia planPatients who are preferred to apply interfascial plane blocks as part of multimodal analgesia in the postoperative analgesia plan will be evaluated in this group. |
| Control | – | Other: Standart analgesia planMultimodal analgesia plans that does not include interfascial plane blocks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent laparoscopic cholecystectomy ASA 1-3. age:18-70
Key inclusion criteria (3 listed)
- ASA 1-3
- Laparoscopic cholecystectomy
- under General Anesthesia
Key exclusion criteria (11 listed)
- Morbidly obesity or cachexia
- local anesthetic allergies
- myopathies
- coagulopathies
- Obstructive sleep apne syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| İnterfascial plane blockInterfascial plane blocks will be added to the routine analgesia plan as part of multimodal analgesia. | Other | Interfascial plane blocks |
| Standart analgesia planThis is the routine analgesia plan applied in our clinic. | Other | Control, Interfascial plane blocks |
Primary outcome
CPK levels
Time frame: at postoperative 24th hour
Serum creatine phosphokinase levels at 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 35221361Rakhi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Tulgar study chair
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myotoxicity, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPK levels (time frame: at postoperative 24th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.