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CompletedNCT06710457Updated Apr 15, 2025

Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting

An interventional study of ESP and No ESP in Anesthesia, Pain, Postoperative and Nausea and Vomiting, Postoperative, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Anesthesia
  • Pain, Postoperative
  • Nausea and Vomiting, Postoperative

Keywords

  • Erector spinae plane block
  • Postoperative nausea vomiting
  • Apfel score
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 81 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 425 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
81 participants (actual)

Study arms

  • Active comparator
    Erector spinae plane (ESP) block

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

    Other: ESP

  • Active comparator
    No Erector spinae plane (ESP) block

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

    Other: No ESP

Interventions

  • OtherESP

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

  • OtherNo ESP

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

06

What researchers measure

Primary outcomes

  1. PONV

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

    Time frame: 24 hours

Secondary outcomes

  1. Severity of nausea

    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

    Time frame: 24 hours

  2. 11 - point numerical rating scale (NRS)

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

    Time frame: 24 hours

  3. Rescue antiemetic requirement

    Number of additional antiemetic applications

    Time frame: 24 hours

  4. Rescue analgesic requirement

    Number of additional analgesic applications

    Time frame: 24 hours

  5. intraoperative opioid requirement

    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.

    Time frame: intraoperative time

07

Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Ankara, Çankaya 06800, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06710457
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Gökhan Erdem (Anesthesiology and Reanimation specialist doctor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Nov 29, 2024
Start date
Dec 11, 2024
Primary completion
Mar 15, 2025
Completion
Apr 14, 2025
Last update
Apr 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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