Spinal Anaesthesia Success in Patients With Previous Lumbar Spine Surgery

NCT07852767 | Not Yet Recruiting

• 1 other identifier: E-62190176-663.05-329411125
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare spinal anesthesia success in adults with and without previous lower back surgery. The main question it aims to answer is: \- Does previous lower back surgery affect the success of spinal anesthesia on the first needle insertion? Participants will receive spinal anaesthesia as part of their usual medical care. Researchers will record needle attempts, procedure time, and anaesthesia effectiveness. Participation will not involve additional procedures or changes to routine care.

Conditions

Spinal Surgery; Spinal Aneshtesia

Keywords

Previous lumbar spine surgery; Neuraxial anesthesia; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Spinal Anaesthesia Success on the First Needle Insertion

  Percentage of patients in whom spinal anaesthesia is successfully performed on the first needle insertion, compared between patients with and without previous lumbar spine surgery.

  During the spinal anaesthesia procedure, on the day of surgery.

Secondary Outcomes (5)

• Total Number of Skin Punctures

  From the first needle insertion until completion or abandonment of the spinal anaesthesia procedure, on the day of surgery.

• Spinal Anaesthesia Procedure Duration

  During the spinal anaesthesia procedure, on the day of surgery.

• Time to Maximum Sensory Block Level

  Following intrathecal injection, on the day of surgery.

• Blood Pressure Changes

  Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.

• Heart Rate Changes

  Before spinal anaesthesia and during the first 30 minutes after intrathecal injection.

Study Arms (2)

Prior Lumbar Surgery Group

Adults with a history of lumbar spine surgery who are scheduled to receive spinal anaesthesia as part of routine care for another surgical procedure.

Procedure: spinal anesthesia

Control Group Without Prior Lumbar Surgery

Adults without a history of lumbar spine surgery who are scheduled to receive spinal anesthesia as part of routine surgical care. This cohort will serve as the comparison group.

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

Single-shot spinal anaesthesia administered as part of routine surgical care in patients with or without previous lumbar spine surgery. The treating anaesthesiologist will determine the puncture site, needle type, approach, and anaesthetic drug and dose according to clinical judgment. Researchers will not assign or modify the procedure and will only collect observational data.

Control Group Without Prior Lumbar Surgery; Prior Lumbar Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older with ASA physical status I-III who are scheduled to receive spinal anaesthesia as part of routine surgical care at Taksim Training and Research Hospital, Istanbul, Turkey. The study population will include patients with previous lumbar spine surgery and a comparison cohort without previous lumbar spine surgery.

You may qualify if:

• Age 18 years or older.
• American Society of Anaesthesiologists (ASA) physical status classification I-III.
• Scheduled to receive clinically indicated spinal anaesthesia for surgery, performed by clinicians other than the researchers collecting study data.
• Provision of written informed consent.

You may not qualify if:

• Any clinical contraindication to spinal anaesthesia.
• Refusal to participate or inability to provide written informed consent.
• Severe cognitive impairment preventing study assessments.
• Planned epidural or combined spinal-epidural anaesthesia.
• Inability to reliably record study data.

Sponsors & Collaborators

• Celal Kaya: lead

Study Sites (1)

Taksim Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Zhu G, Wang X, Yang L. Real-time ultrasound-guided neuraxial anesthesia for cesarean section in parturients with previous internal fixation surgery for lumbar fracture: a case series. Quant Imaging Med Surg. 2023 Jan 1;13(1):529-535. doi: 10.21037/qims-22-223. Epub 2022 Oct 26. No abstract available.

  PMID: 36620151 RESULT

• Kim SH, Jeon DH, Chang CH, Lee SJ, Shin YS. Spinal anesthesia with isobaric tetracaine in patients with previous lumbar spinal surgery. Yonsei Med J. 2009 Apr 30;50(2):252-6. doi: 10.3349/ymj.2009.50.2.252.

  PMID: 19430559 RESULT

• Hebl JR, Horlocker TT, Kopp SL, Schroeder DR. Neuraxial blockade in patients with preexisting spinal stenosis, lumbar disk disease, or prior spine surgery: efficacy and neurologic complications. Anesth Analg. 2010 Dec;111(6):1511-9. doi: 10.1213/ANE.0b013e3181f71234. Epub 2010 Sep 22.

  PMID: 20861423 RESULT

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Celal Kaya

  Taksim Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celal Kaya, MD

CONTACT

905435176760; c.kaya47@hotmail.com

Sena Yildiz, MD

CONTACT

905372630427; dr.senayildiz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Anaesthesiology and Intensive Care

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)