Clinical trial NCT06710457: Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting
Official title: Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting in Lumbar Disc Herniation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Pain, Postoperative
Nausea and Vomiting, Postoperative
Keywords: Erector spinae plane block
Postoperative nausea vomiting
Apfel score
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: PONV
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of nausea
timeFrame: 24 hours
measure: 11 - point numerical rating scale (NRS)
timeFrame: 24 hours
measure: Rescue antiemetic requirement
timeFrame: 24 hours
measure: Rescue analgesic requirement
timeFrame: 24 hours
measure: intraoperative opioid requirement
timeFrame: intraoperative time
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Ankara, Çankaya
Study officials:
References: