Erector Spinae Plane BlockNCT06900413
ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy
A study testing Group ESP and Group EXORA in people with Erector Spinae Plane Block and Laparoscopic Cholecystectomy, run by Aycan KURTARANGİL DOĞAN at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Laparoscopic Cholecystectomy, Plane Block
- What is being tested?
- Group ESP and Group EXORA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 15 Apr 2026
- 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
- Undergoing elective laparoscopic cholecystectomy
- Classified as American Society of Anesthesiologists (ASA) physical status I to III
- Providing written informed consent
Who cannot join
- Known allergy or hypersensitivity to local anesthetics
- Infection or skin lesions at the site of block application
- Emergency surgical procedures
- Refusal to participate in the study
- Uncontrolled arterial hypertension
- Uncontrolled diabetes mellitus
Show all 11Show fewer
- Mental retardation
- Current use of antidepressant medications
- Presence of metabolic disorders
- Known bleeding diathesis
- Morbid obesity (Body Mass Index > 40 kg/m²)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy
Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption.
The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.
- Being tested
- Group ESP, Group EXORA
- Keywords
- Erector Spinae Plane Block, exora block, laparoscopic cholecystectomy, patient-controlled analgesia, plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ESPProcedure or surgery
Experienced anesthesiologists with at least five years of expertise in regional anesthesia will perform the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe (Affiniti 50; Philips) will be used. The ESP block will be applied at the T8 level on the right side, using an in-plane approach, while the patient is in a sitting position. The probe will be placed 2-3 cm lateral to the vertebra in a sagittal position to visualize the erector spinae muscle and transverse processes.
A 22G, 100 mm block needle (Stimuplex® Ultra, Braun, Germany) will be advanced in a craniocaudal direction. The correct needle position will be confirmed by injecting 0.5-1 mL of isotonic NaCl and observing the spread via hydrodissection. Finally, 0.3 mL/kg of 0.25% bupivacaine will be administered, ensuring cranial and caudal spread of the local anesthetic.
Group EXORAProcedure or surgery
Experienced anesthesiologists with at least five years of expertise in regional anesthesia will administer the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe will be placed laterally to the xiphoid process on the parasternal line in a sagittal position. The probe will be moved craniocaudally to identify the 6th rib and further advanced caudally to locate the 8th rib. Once the rectus abdominis muscle and 8th costal cartilage are identified, a 22G, 100 mm block needle will be used to administer 0.3 mL/kg of 0.25% bupivacaine. The correct spread of the local anesthetic will be confirmed via ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Group ESP | Active comparator | The ESP block will be performed approximately 30 minutes before general anesthesia induction following sedation and standard monitoring. All block procedures will be conducted under sterile conditions, with skin preparation using dermol (%70 Isopropyl Alcohol, %2 Chlorhexidine Gluconate) and the ultrasound probe covered with a sterile drape. Receives: Procedure: Group ESP |
| Group EXORA | Active comparator | The EXORA block will be performed 30 minutes before general anesthesia induction, following sedation and standard monitoring. Receives: Procedure: Group EXORA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tramadol consumption
Total tramadol used in the first 12 and 24 hours postoperatively.
Measured: 12 and 24 hours
Secondary outcomes (5)
Visual Analog Scale (VAS) for Pain Assessment
Postoperative pain will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate a worse outcome (more pain). Units on a scale (0-10)
Measured: 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
Pinprick Sensory Block Test Results
Sensory block efficacy will be evaluated using the pinprick test at specified time intervals. The presence or absence of sensory block will be recorded. Binary (Block present / Block absent)
Measured: 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery
Nausea and Vomiting Score (NVS)
Postoperative nausea and vomiting will be evaluated using the Nausea and Vomiting Scale (NVS), which includes:
- = No nausea,
- = Mild nausea,
- = Severe nausea,
- = Vomiting present. Higher scores indicate a worse outcome. Units on a scale (1-4)
Measured: Within 24 hours after surgery
Ramsay Sedation Scale (RSS)
Postoperative sedation will be assessed using the Ramsay Sedation Scale (RSS), which includes:
- = Anxious, agitated, or restless
- = Cooperative, oriented, and tranquil
- = Responds to commands only
- = Brisk response to auditory stimulus
- = Sluggish response to auditory stimulus
- = No response Higher scores indicate a deeper level of sedation. Units on a scale (1-6)
Measured: Within 24 hours after surgery
Additional Analgesic Consumption
The total amount of additional analgesics administered postoperatively will be recorded. Milligrams (mg)
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Oct 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aycan KURTARANGİL DOĞAN
- Sponsor type
- University, hospital or other
- Collaborators
- Kutahya City Hospital
- Responsible party
- Sponsor-investigator, Aycan KURTARANGİL DOĞAN, Kutahya City Hospital
- Investigators
- Aycan KURTARANGİL DOĞAN, Principal investigator, Kütahya City HospitalAli Kaynak, Principal investigator, Kütahya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900413
- Sponsor's protocol ID
- KSH-01
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2025
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06900413
- Acronym / sponsor ID
- KSH-01
- Keywords
- Erector Spinae Plane Block, exora block, laparoscopic cholecystectomy, patient-controlled analgesia, plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aycan KURTARANGİL DOĞANUniversity, hospital or other
- Collaborators
- Kutahya City Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 28 Mar 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.
Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption.
The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESP | Active comparator | Procedure: Group ESPThe ESP block will be performed approximately 30 minutes before general anesthesia induction following sedation and standard monitoring. All block procedures will be conducted under sterile conditions, with skin preparation using dermol (%70 Isopropyl Alcohol, %2 Chlorhexidine Gluconate) and the ultrasound probe covered with a sterile drape. |
| Group EXORA | Active comparator | Procedure: Group EXORAThe EXORA block will be performed 30 minutes before general anesthesia induction, following sedation and standard monitoring. |
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
- Undergoing elective laparoscopic cholecystectomy
- Classified as American Society of Anesthesiologists (ASA) physical status I to III
- Providing written informed consent
Key exclusion criteria (11 listed)
- Known allergy or hypersensitivity to local anesthetics
- Infection or skin lesions at the site of block application
- Emergency surgical procedures
- Refusal to participate in the study
- Uncontrolled arterial hypertension
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 |
|---|---|---|
| Group ESPExperienced anesthesiologists with at least five years of expertise in regional anesthesia will perform the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe (Affiniti 50; Philips) will be used. The ESP block will be applied at the T8 level on the right side, using an in-plane approach, while the patient is in a sitting position. The probe will be placed 2-3 cm lateral to the vertebra in a sagittal position to visualize the erector spinae muscle and transverse processes. A 22G, 100 mm block needle (Stimuplex® Ultra, Braun, Germany) will be advanced in a craniocaudal direction. The correct needle position will be confirmed by injecting 0.5-1 mL of isotonic NaCl and observing the spread via hydrodissection. Finally, 0.3 mL/kg of 0.25% bupivacaine will be administered, ensuring cranial and caudal spread of the local anesthetic. | Procedure or surgery | Group ESP |
| Group EXORAExperienced anesthesiologists with at least five years of expertise in regional anesthesia will administer the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe will be placed laterally to the xiphoid process on the parasternal line in a sagittal position. The probe will be moved craniocaudally to identify the 6th rib and further advanced caudally to locate the 8th rib. Once the rectus abdominis muscle and 8th costal cartilage are identified, a 22G, 100 mm block needle will be used to administer 0.3 mL/kg of 0.25% bupivacaine. The correct spread of the local anesthetic will be confirmed via ultrasound. | Procedure or surgery | Group EXORA |
Primary outcome
Tramadol consumption
Time frame: 12 and 24 hours
Total tramadol used in the first 12 and 24 hours postoperatively.
5 secondary outcomes
Visual Analog Scale (VAS) for Pain Assessment
Time frame: 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
Pinprick Sensory Block Test Results
Time frame: 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery
Nausea and Vomiting Score (NVS)
Time frame: Within 24 hours after surgery
Ramsay Sedation Scale (RSS)
Time frame: Within 24 hours after surgery
Additional Analgesic Consumption
Time frame: Within 24 hours after surgery
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 18 Sep 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.
Aycan KURTARANGİL DOĞAN principal investigator
Kütahya City Hospital
Ali Kaynak principal investigator
Kütahya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group ESP and Group EXORA in people with Erector Spinae Plane Block and Laparoscopic Cholecystectomy, run by Aycan KURTARANGİL DOĞAN 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 11 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 18 Sep 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?
Tramadol consumption (time frame: 12 and 24 hours). 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 18 Sep 2026.