NCT06710457

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

December 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

November 26, 2024

Last Update Submit

April 14, 2025

Conditions

Keywords

Erector spinae plane blockPostoperative nausea vomitingApfel score

Outcome Measures

Primary Outcomes (1)

  • PONV

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

    24 hours

Secondary Outcomes (5)

  • Severity of nausea

    24 hours

  • 11 - point numerical rating scale (NRS)

    24 hours

  • Rescue antiemetic requirement

    24 hours

  • Rescue analgesic requirement

    24 hours

  • intraoperative opioid requirement

    intraoperative time

Study Arms (2)

Erector spinae plane (ESP) block

ACTIVE COMPARATOR

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

Other: ESP

No Erector spinae plane (ESP) block

ACTIVE COMPARATOR

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

Other: No ESP

Interventions

ESPOTHER

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

Erector spinae plane (ESP) block
No ESPOTHER

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

No Erector spinae plane (ESP) block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

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

Location

Related Publications (1)

  • Erdem G, Kavak Akelma F, Nalbant B, Gokbulut Ozaslan N. Effect of erector spinae plane block on postoperative nausea and vomiting in lumbar disc herniation surgery. Reg Anesth Pain Med. 2025 Jun 30:rapm-2025-106756. doi: 10.1136/rapm-2025-106756. Online ahead of print.

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation specialist doctor

Study Record Dates

First Submitted

November 26, 2024

First Posted

November 29, 2024

Study Start

December 11, 2024

Primary Completion

March 15, 2025

Study Completion

April 14, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations