Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting

Not Applicable

Completed

• Conditions: Anesthesia; Pain, Postoperative; Nausea and Vomiting, Postoperative

• Registration Number: NCT06710457
• Lead Sponsor: Ankara City Hospital Bilkent

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.

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 Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Study Start: 2024-12-11
• Primary Completion: 2025-03-15
• Status Verified: 2025-04
• Study Completion: 2025-04-14
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PONV	24 hours	The primary outcome of the study was the incidence of postoperative nausea and/or vomiting

Secondary Outcome Measures

Name	Time	Method
Severity of nausea	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
11 - point numerical rating scale (NRS)	24 hours	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Rescue antiemetic requirement	24 hours	Number of additional antiemetic applications
Rescue analgesic requirement	24 hours	Number of additional analgesic applications
intraoperative opioid requirement	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Ankara, Çankaya, Turkey