MyotoxicityNCT05505890
Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty
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 orthopedic surgery. 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 75 years
- Conditions the study is for
- Myotoxicity
- What is being tested?
- suprainguinal fascia iliaca block
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2022to 21 Feb 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing knee artroplasty surgery of ASA status 1-3. aged between 18-75years.
Who may be able to join
- ASA 1-3
- knee artoplasty patients
- under spinal anesthesia
Who cannot join
- local anesthetic allergies
- myopathies
- coagulopathies
- Obstructive sleep apne syndrome
- hearth diseases
- liver diseases
Show all 10Show fewer
- 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
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.
Read the 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.
- Conditions
- Myotoxicity
- Being tested
- suprainguinal fascia iliaca block
- Keywords
- bupivacaine, myotoxicity, creatine phosphokinase,SFIPB
- Medical subject headings
- Myotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprainguinal fascia iliaca blockOther
Suprainguinal fascia iliaca block will be performed after the end of surgery for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| SFIPB | suprainguinal fascia iliaca plane block with 50ml of %0.25 bupivacaine will be used for postoperative analgesia
. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPK levels
Change from Baseline serum creatine phosphokinase at 24 hours
Measured: at postoperative 24th hour
Secondary outcomes (1)
Number of patients requesting rescue analgesics
Intravenous administration of meperidine 25 mg as a rescue analgesic is planned for patients who complain of severe pain despite multimodal analgesia.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start16 Dec 2022
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
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
- 82 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
- NCT05505890
- Sponsor's protocol ID
- SamsunU_SFIPB
- Status last verified
- Feb 2023
- First submitted
- 15 Aug 2022
- Last updated
- 22 Feb 2023
- 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty
- ClinicalTrials.gov ID
- NCT05505890
- Acronym / sponsor ID
- SamsunU_SFIPB
- Conditions
- Myotoxicity
- Keywords
- bupivacaine, myotoxicity, creatine phosphokinase,SFIPB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 18 Aug 2022 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFIPB | – | Other: suprainguinal fascia iliaca blocksuprainguinal fascia iliaca plane block with 50ml of %0.25 bupivacaine will be used for postoperative analgesia . |
| control | – | –Fascia iliac block will not be applied to this group. Postoperative analgesia will be provided with other analgesia modalities. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing knee artroplasty surgery of ASA status 1-3. aged between 18-75years.
Key inclusion criteria (3 listed)
- ASA 1-3
- knee artoplasty patients
- under spinal anesthesia
Key exclusion criteria (10 listed)
- local anesthetic allergies
- myopathies
- coagulopathies
- Obstructive sleep apne syndrome
- hearth diseases
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 |
|---|---|---|
| suprainguinal fascia iliaca blockSuprainguinal fascia iliaca block will be performed after the end of surgery for postoperative analgesia. | Other | SFIPB |
Primary outcome
CPK levels
Time frame: at postoperative 24th hour
Change from Baseline serum creatine phosphokinase at 24 hours
1 secondary outcome
Number of patients requesting rescue analgesics
Time frame: up to 24 hours
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 22 Feb 2023.
- Results publication: 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 10 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 22 Feb 2023. 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 NCT05505890, 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 22 Feb 2023.