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NCT Number: NCT07638280

Non-Pharmacological Factors on Spinal 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

spinal anaesthesia

Procedure

Patients who will undergo surgery required spinal anaesthesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. The spread of the spinal block

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guray Demir, Proffesor

CONTACT

[email protected]

90 5052113989

Leyla Sivacigil, MD

CONTACT

[email protected]

905065983478

Sponsors and collaborators

Lead sponsor

Taksim Egitim ve Arastirma Hastanesi

Other Gov

Registry information

Official study title

Analysis of Non-pharmacological Factors on Spinal Anaesthesia Block Duration

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.