NCT07638280

Brief 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 potential relationships between these factors and block duration.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

April 20, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2026

Last Updated

June 23, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 20, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

anaesthesiaspinal anaesthesiaultrasound

Outcome Measures

Primary Outcomes (1)

  • Paraspinal mass measurement with ultrasound.

    Ultrasonographic measurement of paraspinal muscle thickness (cm) and its association with duration of spinal block will be investigated.

    Pre-operative

Secondary Outcomes (1)

  • The spread of the spinal block

    Perioperative/Periprocedural

Interventions

Patients who will undergo surgery required spinal anaesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-80 years, male and female, classified as ASA physical status I-III, and scheduled for elective lower abdominal surgery.

You may qualify if:

  • Patients aged 18-80 years
  • ASA physical status I-III
  • Patients scheduled for elective lower abdominal surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taksim Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Leyla Sivacigil

    Taksim Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Sivacigil, MD

CONTACT

Guray Demir, Proffesor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

June 10, 2026

Study Start

June 16, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 16, 2026

Last Updated

June 23, 2026

Record last verified: 2026-04

Locations