AnesthesiaNCT06710457
Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting
A study testing ESP and No ESP in people with Anesthesia and Pain, Postoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Pain, Postoperative, Nausea and Vomiting, Postoperative
- What is being tested?
- ESP and No ESP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2024to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above
- ASA physical status I to II
- One lumbar disc herniation surgery under general anesthesia
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, Çankaya, 06800
About this study
Official title: 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.
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.
- Being tested
- ESP, No ESP
- Keywords
- Erector spinae plane block, Postoperative nausea vomiting, Apfel score
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPOther
Patients will receive an erector spinae plane (ESP) block in addition to standard medical treatment to prevent PONV and postoperative pain.
No ESPOther
Patients will receive standard medical treatment to prevent PONV and postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ESP |
| No Erector spinae plane (ESP) block | Active comparator | Patients will receive standard medical treatment to prevent PONV and postoperative pain. Receives: Other: No ESP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV
The primary outcome of the study was the incidence of postoperative nausea and/or vomiting
Measured: 24 hours
Secondary outcomes (5)
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
Measured: 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.
Measured: 24 hours
Rescue antiemetic requirement
Number of additional antiemetic applications
Measured: 24 hours
Rescue analgesic requirement
Number of additional analgesic applications
Measured: 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.
Measured: intraoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start11 Dec 2024
- Primary completion15 Mar 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Erdem, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710457
- Sponsor's protocol ID
- ESP PONV
- Status last verified
- Apr 2025
- First submitted
- 26 Nov 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jun 5;51(6):674-680. doi: 10.1136/rapm-2025-106756.
PubMed 40588358
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting in Lumbar Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT06710457
- Acronym / sponsor ID
- ESP PONV
- Keywords
- Erector spinae plane block, Postoperative nausea vomiting, Apfel score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane (ESP) block | Active comparator | Other: ESPPatients will receive an erector spinae plane (ESP) block in addition to standard medical treatment to prevent PONV and postoperative pain. |
| No Erector spinae plane (ESP) block | Active comparator | Other: No ESPPatients will receive standard medical treatment to prevent PONV and postoperative pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above
- ASA physical status I to II
- One lumbar disc herniation surgery under general anesthesia
Key exclusion criteria (17 listed)
- body mass index >35 kg/m²)
- history of drug use
- nausea and vomiting before surgery
- psychiatric disorders
- use of antipsychotic or antiemetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPPatients will receive an erector spinae plane (ESP) block in addition to standard medical treatment to prevent PONV and postoperative pain. | Other | Erector spinae plane (ESP) block |
| No ESPPatients will receive standard medical treatment to prevent PONV and postoperative pain. | Other | No Erector spinae plane (ESP) block |
Primary outcome
PONV
Time frame: 24 hours
The primary outcome of the study was the incidence of postoperative nausea and/or vomiting
5 secondary outcomes
Severity of nausea
Time frame: 24 hours
11 - point numerical rating scale (NRS)
Time frame: 24 hours
Rescue antiemetic requirement
Time frame: 24 hours
Rescue analgesic requirement
Time frame: 24 hours
intraoperative opioid requirement
Time frame: intraoperative time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Derived from this study: PubMed 40588358Erdem 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. 2026 Jun 5;51(6):674-680. doi: 10.1136/rapm-2025-106756.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP and No ESP in people with Anesthesia and Pain, Postoperative, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06710457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.