Postoperative PainESP-POSTURENCT07018258
Optimal Patient Positioning for Erector Spinae Plane Block in Laparoscopic Cholecystectomy:
A study testing Erector Spinae Plane (ESP) Block in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy, Anesthesia, Regional
- What is being tested?
- Erector Spinae Plane (ESP) Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2025to 10 Dec 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
- Age between 18 and 65 years
- Scheduled for elective laparoscopic cholecystectomy
- ASA physical status I-II
- Ability to understand and provide written informed consent
Who cannot join
- Allergy to local anesthetics
- History of chronic opioid use or substance abuse
- Coagulopathy or current anticoagulant therapy
- Local infection at the block site
- Severe spinal deformities or scoliosis
- BMI > 35 kg/m²
- Pregnancy or breastfeeding
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Patient Positioning for Erector Spinae Plane Block: Effects on Postoperative Analgesia and Patient Satisfaction"
This randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. The study also evaluates the variation in skin-to-block site distance depending on patient positioning.
Read the detailed description
Erector spinae plane (ESP) block is a relatively recent regional anesthesia technique performed under ultrasound guidance, widely used for managing acute postoperative pain. While the ESP block is known for its safety, simplicity, and versatility, there is limited evidence regarding the influence of patient positioning on its clinical effectiveness and technical performance.
This prospective, randomized, single-blind study investigates the impact of administering bilateral ESP block at the T7 vertebral level in three different patient positions: lateral decubitus, prone, and sitting. The study includes adult patients (aged 18-65, ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia.
Primary outcomes include postoperative pain scores (VAS and NRS). Secondary outcomes include total rescue analgesic consumption (tramadol), time to first analgesic requirement, patient satisfaction scores (Likert scale), and measurement of the skin-to-block site distance across different positions. Data will be collected at defined intervals up to 24 hours postoperatively.
The findings are expected to inform clinicians on the optimal patient positioning for ESP block to enhance block efficacy and patient comfort during laparoscopic abdominal surgery.
- Being tested
- Erector Spinae Plane (ESP) Block
- Keywords
- Erector Spinae Plane Block, Patient Positioning, Ultrasound-Guided Regional Anesthesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane (ESP) BlockProcedure or surgery
Also called Ultrasound-guided ESP block
Ultrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Position Group | Experimental | Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy. Receives: Procedure: Erector Spinae Plane (ESP) Block |
| Prone Position Group | Experimental | Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy. Receives: Procedure: Erector Spinae Plane (ESP) Block |
| Sitting Position Group | Experimental | Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy. Receives: Procedure: Erector Spinae Plane (ESP) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at multiple time points following laparoscopic cholecystectomy. The goal is to compare postoperative pain scores between patient groups receiving ESP block in lateral, prone, or sitting positions.
Measured: 0, 2, 4, 6, 12, and 24 hours postoperatively
Secondary outcomes (4)
Total Postoperative Analgesic Consumption
The cumulative dose (mg) of tramadol administered as rescue analgesia within the first 24 hours postoperatively will be recorded for each group.
Measured: First 24 hours after surgery
Time to First Analgesic Request
The duration (in minutes) between the end of surgery and the patient's first request for additional analgesia.
Measured: Within 24 hours postoperatively
Patient Satisfaction Score
Patient satisfaction will be assessed at 24 hours postoperatively using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Measured: 24 hours postoperatively
Skin-to-Target Distance
The distance (in millimeters) from the skin to the ESP block site will be measured via ultrasound at the T7 level in each patient position to determine anatomical variation.
Measured: During preoperative ESP block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start27 Jun 2025
- Primary completion10 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Model description
- Patients will be randomly assigned to receive ESP block in either the lateral, prone, or sitting position prior to laparoscopic cholecystectomy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Fahri Pehlivan, Harran University
- Investigators
- Veli F Pehlivan, Asiss Prof, Principal investigator, Harran University Faculty of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018258
- Sponsor's protocol ID
- Cevher
- Acronym
- ESP-POSTURE
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Patient Positioning for Erector Spinae Plane Block: Effects on Postoperative Analgesia and Patient Satisfaction"
- ClinicalTrials.gov ID
- NCT07018258
- Acronym / sponsor ID
- ESP-POSTURE / Cevher
- Keywords
- Erector Spinae Plane Block, Patient Positioning, Ultrasound-Guided Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 12 Jun 2025 (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 randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. The study also evaluates the variation in skin-to-block site distance depending on patient positioning.
Detailed description
Erector spinae plane (ESP) block is a relatively recent regional anesthesia technique performed under ultrasound guidance, widely used for managing acute postoperative pain. While the ESP block is known for its safety, simplicity, and versatility, there is limited evidence regarding the influence of patient positioning on its clinical effectiveness and technical performance.
This prospective, randomized, single-blind study investigates the impact of administering bilateral ESP block at the T7 vertebral level in three different patient positions: lateral decubitus, prone, and sitting. The study includes adult patients (aged 18-65, ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia.
Primary outcomes include postoperative pain scores (VAS and NRS). Secondary outcomes include total rescue analgesic consumption (tramadol), time to first analgesic requirement, patient satisfaction scores (Likert scale), and measurement of the skin-to-block site distance across different positions. Data will be collected at defined intervals up to 24 hours postoperatively.
The findings are expected to inform clinicians on the optimal patient positioning for ESP block to enhance block efficacy and patient comfort during laparoscopic abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomly assigned to receive ESP block in either the lateral, prone, or sitting position prior to laparoscopic cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| Lateral Position Group | Experimental | Procedure: Erector Spinae Plane (ESP) BlockPatients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy. |
| Prone Position Group | Experimental | Procedure: Erector Spinae Plane (ESP) BlockPatients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy. |
| Sitting Position Group | Experimental | Procedure: Erector Spinae Plane (ESP) BlockPatients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Scheduled for elective laparoscopic cholecystectomy
- ASA physical status I-II
- Ability to understand and provide written informed consent
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- History of chronic opioid use or substance abuse
- Coagulopathy or current anticoagulant therapy
- Local infection at the block site
- Severe spinal deformities or scoliosis
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 |
|---|---|---|
| Erector Spinae Plane (ESP) BlockAlso: Ultrasound-guided ESP blockUltrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy. | Procedure or surgery | Lateral Position Group, Prone Position Group, Sitting Position Group |
Primary outcome
Postoperative Pain Score (VAS)
Time frame: 0, 2, 4, 6, 12, and 24 hours postoperatively
Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at multiple time points following laparoscopic cholecystectomy. The goal is to compare postoperative pain scores between patient groups receiving ESP block in lateral, prone, or sitting positions.
4 secondary outcomes
Total Postoperative Analgesic Consumption
Time frame: First 24 hours after surgery
Time to First Analgesic Request
Time frame: Within 24 hours postoperatively
Patient Satisfaction Score
Time frame: 24 hours postoperatively
Skin-to-Target Distance
Time frame: During preoperative ESP block procedure
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 27 Feb 2026.
- 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.
Veli F Pehlivan, Asiss Prof principal investigator
Harran University Faculty of Medicine, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane (ESP) Block in people with Postoperative Pain and Laparoscopic Cholecystectomy, 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 4 inclusion and 8 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 27 Feb 2026. 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?
Postoperative Pain Score (VAS) (time frame: 0, 2, 4, 6, 12, and 24 hours postoperatively). 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 27 Feb 2026.