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Active, Not Recruiting

NCT Number: NCT07697651

Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women

This prospective observational study will evaluate postoperative hearing changes in women undergoing elective cesarean delivery under spinal anesthesia. Pure-tone audiometry will be performed before spinal anesthesia and at the predefined postoperative assessment time. The incidence, onset time, and severity of post-dural puncture headache (PDPH) will also be assessed. The study aims to determine whether hearing threshold changes occur after spinal anesthesia and whether these changes are associated with PDPH.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

Spinal anesthesia is routinely used for elective cesarean delivery. Dural puncture may be associated with cerebrospinal fluid pressure changes that can affect inner-ear fluid dynamics and may result in transient changes in hearing thresholds. Post-dural puncture headache is another clinically relevant complication that may reflect cerebrospinal fluid loss and pressure changes.

Eligible women scheduled for elective cesarean delivery under spinal anesthesia will be enrolled consecutively after providing written informed consent. Spinal anesthesia will be administered according to routine clinical practice, with no additional anesthetic intervention performed for research purposes. Demographic and perioperative variables, including spinal needle gauge, sensory block level, hemodynamic measurements, vasopressor use, and occurrence of post-dural puncture headache, will be recorded. Pure-tone audiometry will be performed before surgery and at the predefined postoperative assessment time. Postoperative hearing thresholds will be compared with baseline values, and their association with post-dural puncture headache will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Women aged 18 years or older.
  • Scheduled for elective cesarean delivery.
  • Planned spinal anesthesia.
  • ASA physical status I-II [revise if another ASA range is approved in the protocol].
  • Ability to complete preoperative and postoperative pure-tone audiometry assessments.
  • Provision of written informed consent.

Exclusion criteria

  • • Pre-existing hearing loss, use of hearing aids, or inability to complete audiometric testing.
  • History of chronic otologic disease, ear surgery, or active ear infection.
  • Contraindication to spinal anesthesia.
  • Conversion to general anesthesia before completion of the protocol assessments.
  • Refusal to participate or withdrawal of consent.
  • [Add any protocol-specific exclusions approved by the ethics committee, such as chronic headache disorder, hypertensive disease of pregnancy, or major perioperative hemorrhage, only if applicable.

Treatment and study plan

Primary outcomes

  1. Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia

    Time frame: : Baseline preoperative assessment to postoperative audiometric assessment at 48 hours after spinal anesthesia

    The primary outcome is the difference between preoperative and postoperative pure-tone audiometry thresholds at the tested frequencies in each ear. Hearing thresholds will be recorded in decibels hearing level (dB HL), and the change from baseline will be analyzed

Other outcomes

  1. Association Between Hearing Threshold Changes and Post-Dural Puncture Headache

    Time frame: Within 7 days after spinal anesthesia.

    Association between postoperative changes in hearing thresholds and the occurrence of post-dural puncture headache.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 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.

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