- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07638280
Non-Pharmacological Factors on Spinal Block Duration
Analysis of Non-pharmacological Factors on Spinal Anaesthesia Block Duration
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Leyla Sivacigil, MD
- Telefonnummer: 905065983478
- E-post: veralleyla@hotmail.com
Studera Kontakt Backup
- Namn: Guray Demir, Proffesor
- Telefonnummer: 90 5052113989
- E-post: guraydemir@gmail.com
Studieorter
-
-
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Istanbul, Turkiet (Türkiye), 34000
- Rekrytering
- Taksim Training and Research Hospital
-
Kontakt:
- Leyla Sivacigil, MD
- Telefonnummer: 905065983478
- E-post: veralleyla@hotmail.com
-
Huvudutredare:
- Leyla Sivacigil, MD
-
Kontakt:
- Guray Demir, Proffesor
- Telefonnummer: 905052113989
- E-post: guraydemir@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients aged 18-80 years
- ASA physical status I-III
- Patients scheduled for elective lower abdominal surgery.
Exclusion Criteria:
- Patient refusal to participate
- Coagulopathy
- Use of medications or substances known to impair coagulation
- Pregnancy, sepsis
- Shock
- Severe aortic or mitral regurgitation
- Peripheral vascular disease
- Increased intracranial pressure
- Mental disorders
- Spinal column deformity
- History of previous spinal surgery.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Paraspinal mass measurement with ultrasound.
Tidsram: Pre-operative
|
Ultrasonographic measurement of paraspinal muscle thickness (cm) and its association with duration of spinal block will be investigated.
|
Pre-operative
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The spread of the spinal block
Tidsram: Perioperative/Periprocedural
|
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. |
Perioperative/Periprocedural
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Leyla Sivacigil, Taksim Training and Research Hospital
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Paliwal 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.
- Belavy 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026.02.IRB.121
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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