Paraspinal Muscle Mass and Spinal AnaesthesiaNCT07638280
Non-Pharmacological Factors on Spinal Block Duration
An observational study of Paraspinal Muscle Mass and Spinal Anaesthesia, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of non-pharmacological factors-such as age, sex, body mass index, paraspinal muscle mass, vertebral canal anatomy, patient positioning, and injection technique-on the duration of sensory and motor block in patients undergoing spinal anesthesia, and to investigate the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paraspinal Muscle Mass and Spinal Anaesthesia
- What is being tested?
- spinal anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2026to 29 Sep 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-80 years, male and female, classified as ASA physical status I-III, and scheduled for elective lower abdominal surgery.
Who may be able to join
- Patients aged 18-80 years
- ASA physical status I-III
- Patients scheduled for elective lower abdominal surgery.
Who cannot join
- Patient refusal to participate
- Coagulopathy
- Use of medications or substances known to impair coagulation
- Pregnancy, sepsis
- Shock
- Severe aortic or mitral regurgitation
Show all 11Show fewer
- Peripheral vascular disease
- Increased intracranial pressure
- Mental disorders
- Spinal column deformity
- History of previous spinal surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Taksim Training and Research Hospital
Istanbul, 34000
About this study
Official title: Analysis of Non-pharmacological Factors on Spinal Anaesthesia Block Duration
The aim of this study is to evaluate the effects of non-pharmacological factors-such as age, sex, body mass index, paraspinal muscle mass, vertebral canal anatomy, patient positioning, and injection technique-on the duration of sensory and motor block in patients undergoing spinal anesthesia, and to investigate the potential relationships between these factors and block duration.
Read the detailed description
It is well known that the level of sensory and motor block following spinal anesthesia varies among individuals. This variability is not only related to the dose of local anesthetic but has also been reported to be associated with patient-related non-pharmacological factors. In particular, a relationship has been demonstrated between body mass index (BMI) and both the level and duration of spinal block, with higher block levels and prolonged block duration observed in patients with increased BMI. This phenomenon is thought to be associated with epidural venous distension due to increased intra-abdominal pressure and a reduction in subarachnoid cerebrospinal fluid (CSF) volume. A decrease in CSF volume may facilitate greater cephalad spread of intrathecal local anesthetic agents, thereby prolonging block duration.
Paraspinal muscle mass is also an important anatomical parameter that may influence intra-abdominal pressure and epidural space compliance, and thus may play a determining role in the spread of spinal anesthesia. However, although several studies have investigated the relationship between BMI and body composition and spinal block characteristics, the number of clinical studies directly evaluating the association between ultrasonographically measured paraspinal muscle mass and spinal anesthesia block duration remains limited. Therefore, ultrasonographic measurement of paraspinal muscle thickness may serve as a potential predictor of spinal block duration.
- Being tested
- spinal anaesthesia
- Keywords
- anaesthesia, spinal anaesthesia, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anaesthesiaProcedure or surgery
Patients who will undergo surgery required spinal anaesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Paraspinal mass measurement with ultrasound.
Ultrasonographic measurement of paraspinal muscle thickness (cm) and its association with duration of spinal block will be investigated.
Measured: Pre-operative
Secondary outcomes (1)
The spread of the spinal block
The speed of the sensational block will be measured after spinal anaesthesia performed.
Time(minute) will be recorded when T10 level sensational block is achieved.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start16 Jun 2026
- Primary completion28 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Paraspinal Muscle Mass and Spinal AnaesthesiaStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Leyla Sivacigil, Principal investigator, Taksim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638280
- Sponsor's protocol ID
- 2026.02.IRB.121
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All the statistical data will be shared if required
Publications
Kahveci M, Ugur L. The Effect of Injection Parameters on Drug Distribution for Spinal Anesthesia: A Numerical Approach. J Clin Med. 2025 Sep 3;14(17):6236. doi: 10.3390/jcm14176236.
PubMed 40943995Paliwal N, Khan IA. Exploring Variability in Spinal Anesthesia Levels Achieved During Cesarean Section Deliveries: A Narrative Review. Cureus. 2025 Jul 21;17(7):e88429. doi: 10.7759/cureus.88429. eCollection 2025 Jul.
PubMed 40842780Belavy DL, Armbrecht G, Felsenberg D. Real-time ultrasound measures of lumbar erector spinae and multifidus: reliability and comparison to magnetic resonance imaging. Physiol Meas. 2015 Nov;36(11):2285-99. doi: 10.1088/0967-3334/36/11/2285. Epub 2015 Oct 9.
PubMed 26450474
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Non-pharmacological Factors on Spinal Anaesthesia Block Duration
- ClinicalTrials.gov ID
- NCT07638280
- Acronym / sponsor ID
- 2026.02.IRB.121
- Keywords
- anaesthesia, spinal anaesthesia, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 10 Jun 2026 (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.
The aim of this study is to evaluate the effects of non-pharmacological factors-such as age, sex, body mass index, paraspinal muscle mass, vertebral canal anatomy, patient positioning, and injection technique-on the duration of sensory and motor block in patients undergoing spinal anesthesia, and to investigate the potential relationships between these factors and block duration.
Detailed description
It is well known that the level of sensory and motor block following spinal anesthesia varies among individuals. This variability is not only related to the dose of local anesthetic but has also been reported to be associated with patient-related non-pharmacological factors. In particular, a relationship has been demonstrated between body mass index (BMI) and both the level and duration of spinal block, with higher block levels and prolonged block duration observed in patients with increased BMI. This phenomenon is thought to be associated with epidural venous distension due to increased intra-abdominal pressure and a reduction in subarachnoid cerebrospinal fluid (CSF) volume. A decrease in CSF volume may facilitate greater cephalad spread of intrathecal local anesthetic agents, thereby prolonging block duration.
Paraspinal muscle mass is also an important anatomical parameter that may influence intra-abdominal pressure and epidural space compliance, and thus may play a determining role in the spread of spinal anesthesia. However, although several studies have investigated the relationship between BMI and body composition and spinal block characteristics, the number of clinical studies directly evaluating the association between ultrasonographically measured paraspinal muscle mass and spinal anesthesia block duration remains limited. Therefore, ultrasonographic measurement of paraspinal muscle thickness may serve as a potential predictor of spinal block duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 years, male and female, classified as ASA physical status I-III, and scheduled for elective lower abdominal surgery.
Key inclusion criteria (3 listed)
- Patients aged 18-80 years
- ASA physical status I-III
- Patients scheduled for elective lower abdominal surgery.
Key exclusion criteria (11 listed)
- Patient refusal to participate
- Coagulopathy
- Use of medications or substances known to impair coagulation
- Pregnancy, sepsis
- Shock
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 |
|---|---|---|
| spinal anaesthesiaPatients who will undergo surgery required spinal anaesthesia | Procedure or surgery | – |
Primary outcome
Paraspinal mass measurement with ultrasound.
Time frame: Pre-operative
Ultrasonographic measurement of paraspinal muscle thickness (cm) and its association with duration of spinal block will be investigated.
1 secondary outcome
The spread of the spinal block
Time frame: Perioperative/Periprocedural
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 5 Oct 2026.
- Results publication: PubMed 40943995Kahveci M, Ugur L. The Effect of Injection Parameters on Drug Distribution for Spinal Anesthesia: A Numerical Approach. J Clin Med. 2025 Sep 3;14(17):6236. doi: 10.3390/jcm14176236.
- Results publication: PubMed 40842780Paliwal N, Khan IA. Exploring Variability in Spinal Anesthesia Levels Achieved During Cesarean Section Deliveries: A Narrative Review. Cureus. 2025 Jul 21;17(7):e88429. doi: 10.7759/cureus.88429. eCollection 2025 Jul.
- Results publication: PubMed 26450474Belavy DL, Armbrecht G, Felsenberg D. Real-time ultrasound measures of lumbar erector spinae and multifidus: reliability and comparison to magnetic resonance imaging. Physiol Meas. 2015 Nov;36(11):2285-99. doi: 10.1088/0967-3334/36/11/2285. Epub 2015 Oct 9.
- Individual participant dataSharing planned: Undecided. All the statistical data will be shared if required
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.
Leyla Sivacigil principal investigator
Taksim Training and Research Hospital
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 Paraspinal Muscle Mass and Spinal Anaesthesia, run by Taksim Egitim ve Arastirma Hastanesi 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 5 Oct 2026. 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?
Paraspinal mass measurement with ultrasound. (time frame: Pre-operative). 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 NCT07638280, which also lists 3 linked publications.
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 5 Oct 2026.