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Completed

NCT Number: NCT06710457

Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting

This study will investigate the hypothesis that preoperative erector spinae plane (ESP) block will reduce the incidence of postoperative nausea and vomiting (PONV) in patients undergoing elective lumbar disc herniation (LDH) surgery. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

The study will include patients aged 18 years and older, with (American Society of Anesthesiologists) ASA physical status I and II, and scheduled for single-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.), Apfel score, postoperative nausea and vomiting (PONV) status, intraoperative opioid use requirement, surgical duration, postoperative pain status, rescue analgesic and emetic requirement will be recorded. The primary outcome parameter will be the PONV incidence within the postoperative 24 hours. PONV severity during this period will be assessed using a Likert scale from 0 to 10. PONV will be defined as vomiting, marked nausea (numerical rating scale [NRS] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using the Likert scale. Nausea and its severity, vomiting attacks, need for intraoperative opioid use, pain and its severity, need for additional analgesics, and administration of antiemetic rescue medication will be evaluated as secondary outcome parameters.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 and above
  • ASA physical status I to II
  • One lumbar disc herniation surgery under general anesthesia

Exclusion criteria

  • body mass index >35 kg/m²)
  • history of drug use
  • nausea and vomiting before surgery
  • psychiatric disorders
  • use of antipsychotic or antiemetic drugs
  • severe heart disease
  • central nervous system diseases
  • vertebrobasilar artery insufficiency
  • cytostatic therapy
  • vestibular diseases
  • renal and/or hepatic dysfunction
  • pregnant patients
  • presence of bleeding diathesis
  • patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)
  • patient's refusal to accept the block procedure
  • allergy to local anesthetics
  • injection site infection

Treatment and study plan

ESP

Other

Patients will receive an erector spinae plane (ESP) block in addition to standard medical treatment to prevent PONV and postoperative pain.

No ESP

Other

Patients will receive standard medical treatment to prevent PONV and postoperative pain.

Primary outcomes

  1. PONV

    Time frame: 24 hours

    The primary outcome of the study was the incidence of postoperative nausea and/or vomiting

Secondary outcomes

  1. Severity of nausea

    Time frame: 24 hours

    The degree of nausea was evaluated using the visual analogue scale (VAS), with 0 indicating no nausea or vomiting and 10 indicating the most severe form of unbearable nausea or vomiting. When the PONV score was greater than 4 or vomiting occurs

  2. 11 - point numerical rating scale (NRS)

    Time frame: 24 hours

    11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

  3. Rescue antiemetic requirement

    Time frame: 24 hours

    Number of additional antiemetic applications

  4. Rescue analgesic requirement

    Time frame: 24 hours

    Number of additional analgesic applications

  5. intraoperative opioid requirement

    Time frame: intraoperative time

    To maintain the bispectral index (BIS) between 40-60, remifentanil will be initiated and titrated between 0.05-0.25 mcg/kg/min, taking into account a 20% increase in MAP (mean arterial pressure) compared to the initial value and a 15% increase in heart rate compared to the initial value.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting in Lumbar Disc Herniation Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Apr 15, 2025

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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