Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Other: ESP; Other: No ESP

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Çankaya
    • Ankara, Ankara, Çankaya, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patients will receive an erector spinae plane (ESP) block in addition to standard medical treatment to prevent PONV and postoperative pain.
Active Comparator: No Erector spinae plane (ESP) block; Patients will receive standard medical treatment to prevent PONV and postoperative pain.	Other: No ESP; Patients will receive standard medical treatment to prevent PONV and postoperative pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	The primary outcome of the study was the incidence of postoperative nausea and/or vomiting	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours
11 - point numerical rating scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours
Rescue antiemetic requirement	Number of additional antiemetic applications	24 hours
Rescue analgesic requirement	Number of additional analgesic applications	24 hours
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.	intraoperative time

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): April 14, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Erector spinae plane block; Postoperative nausea vomiting; Apfel score
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: ESP PONV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No