Erector Spinae Plane BlockNCT06670313
Effect of Preop and Postop ESP Block on Analgesia, Hemodynamics and Patient Satisfaction in Laparoscopic Cholecystectomy
A study testing postop Erector spinae plane block in people with Erector Spinae Plane Block, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- postop Erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2024to 25 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the physical classification of the American Society of Anesthesiologists (ASA), ASA I-II group,
- between the ages of 18-65,
Who cannot join
- Patients who do not want to participate in the study;
- BMI >30,
- Patients with contraindications for ESP block,
- Uncooperative patients,
- Those with renal failure,
- Those with hepatic failure and
- ASA III-IV-V group patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoperative and Postoperative Errector Spinal Plan (ESP) Block on Postoperative Analgesia Score, Hemodynamic Response and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy Surgery
Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement.
Read the detailed description
Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement. The first report related to this block was published in 2016; the block was performed to reduce thoracic neuropathic pain in a patient with metastatic rib disease and rib fracture. So far, the block has been reported to be performed successfully in many cases, including the Nuss procedure, thoracotomies, percutaneous nephrolithotomies, ventral hernia surgeries, and even lumbar fusions.
- Conditions
- Erector Spinae Plane Block
- Being tested
- postop Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postop Erector spinae plane blockOther
Postoperative ESP block was performed as the control group
| Study group | Role | What they receive |
|---|---|---|
| Preop Erector spinae plane block | Active comparator | Patients who underwent erector spinae block before surgery Receives: Other: postop Erector spinae plane block |
| postop Erector spinae plane block | Active comparator | Patients who underwent erector spinae block without waking the patient at the end of surgery Receives: Other: postop Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
- Systolic arterial pressure,
Measured: one day
Secondary outcomes (1)
Sevondary outcome
- Postoperative NRS (Numerical pain scale) score,
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start11 Nov 2024
- Primary completion12 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Fahri Pehlivan, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670313
- Sponsor's protocol ID
- Sait
- Status last verified
- Jun 2025
- First submitted
- 25 Oct 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative and Postoperative Errector Spinal Plan (ESP) Block on Postoperative Analgesia Score, Hemodynamic Response and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06670313
- Acronym / sponsor ID
- Sait
- Conditions
- Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 1 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.
Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement.
Detailed description
Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement. The first report related to this block was published in 2016; the block was performed to reduce thoracic neuropathic pain in a patient with metastatic rib disease and rib fracture. So far, the block has been reported to be performed successfully in many cases, including the Nuss procedure, thoracotomies, percutaneous nephrolithotomies, ventral hernia surgeries, and even lumbar fusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preop Erector spinae plane block | Active comparator | Other: postop Erector spinae plane blockPatients who underwent erector spinae block before surgery |
| postop Erector spinae plane block | Active comparator | Other: postop Erector spinae plane blockPatients who underwent erector spinae block without waking the patient at the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- According to the physical classification of the American Society of Anesthesiologists (ASA), ASA I-II group,
- between the ages of 18-65,
Key exclusion criteria (7 listed)
- Patients who do not want to participate in the study;
- BMI >30,
- Patients with contraindications for ESP block,
- Uncooperative patients,
- Those with renal failure,
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 |
|---|---|---|
| postop Erector spinae plane blockPostoperative ESP block was performed as the control group | Other | Preop Erector spinae plane block, postop Erector spinae plane block |
Primary outcome
primary outcome
Time frame: one day
1. Systolic arterial pressure,
1 secondary outcome
Sevondary outcome
Time frame: one day
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 29 Jun 2025.
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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 postop Erector spinae plane block in people with Erector Spinae Plane Block, run by Harran University 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 2 inclusion and 7 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 29 Jun 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?
primary outcome (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.