Erector Spinae Plane BlockNCT07185607
Effect of the Erector Spinae Plane Block in on Robotic Colorectal Surgery
A study testing Erector spinae plane block (ESPB) in people with Erector Spinae Plane Block and Robotic Surgery, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this study is to demonstrate whether the Erector Spinae Plane Block provides effective analgesia in patients undergoing robotic colorectal surgery and whether it contributes positively to the postoperative process. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Erector Spinae Plane Block, Robotic Surgery, Postoperative Pain Management
- What is being tested?
- Erector spinae plane block (ESPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Male and female gender
- Ages 18-75
- Malignant patients undergoing robotic colorectal surgery
Who cannot join
- ASA>III
- Coagulopathy
- Morbid obesity
- History of chronic analgesic use
- Data loss due to limited cooperation during NRS follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Istanbul, 34480
About this study
Official title: Effect of the Erector Spinae Plane Block in Patients Undergoing Robotic Colorectal Surgery
The primary objective of this study is to demonstrate whether the Erector Spinae Plane Block provides effective analgesia in patients undergoing robotic colorectal surgery and whether it contributes positively to the postoperative process.
With the advantages of ultrasound in recent years, the application of regional anesthesia methods such as trunk and peripheral nerve blocks has become a crucial component of multimodal analgesia strategies in postoperative pain management. Among regional techniques, the erector spinae plane block, in particular, has been shown to provide effective analgesia after numerous surgeries in recent years and is increasingly being used. Because the erector spinae plane block provides effective analgesia in a wide range of thoracic and abdominal surgeries, such as thoracotomy, cholecystectomy, and bariatric surgery, and because it is a simple and safe block, it is gaining increasing acceptance in daily practice for the treatment of chronic and acute pain. The aim of postoperative analgesia management is to provide effective analgesia by using multimodal techniques, thus reducing opioid consumption and related complications, providing early mobilization and shorter hospital stay, and increasing patient comfort.
Read the detailed description
Once the effectiveness of the Erector Spinae Plane Block has been demonstrated in patients undergoing robotic colorectal surgery, it will be implemented routinely in our clinic, aiming to reduce postoperative narcotic analgesic consumption, protect patients from narcotic analgesic side effects, facilitate early patient mobilization, shorten hospital stays, and increase patient comfort.
Because no additional procedures or medications were administered to patients outside of routine procedures, no additional risks are anticipated.
Pain is a subjective symptom, and to minimize interpatient variability, it will be assessed using the Numeric Rating Scale (NRS), a standardized scale.
The Postoperative Nausea Vomiting Impact Scale Score will be used to assess postoperative nausea and vomiting.
All volunteers participating in the study, whether or not a block is applied, will receive intravenous analgesia postoperatively using patient-controlled analgesia devices containing 4 mg/ml tramadol, with no basal infusion, a lockout time of 30 minutes, a bolus dose of 3 ml, and no baseline infusion. Data on the time of patients' first analgesic needs, the total number of analgesic requests and at what time, and the total tramadol dose administered will be obtained and recorded from the PCA devices.
- Conditions
- Erector Spinae Plane Block, Robotic Surgery, Postoperative Pain Management, Colorectal Surgery
- Being tested
- Erector spinae plane block (ESPB)
- Keywords
- erector spinae plane block, robotic surgery, postoperative pain management, colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (ESPB)Procedure or surgery
Erector spinae plane block is not a drug or a device. It is a regional method for anesthesia/analgesia. Before block application, patients were placed in a sitting position. A preliminary examination with a high-frequency linear probe was performed to identify the application site. Sterile conditions were then established. An ultrasound probe was longitudinally placed approximately 2 cm lateral to the T11 spinous process. The transverse process was visualized. 1 ml of 2% lidocaine was applied to the estimated needle entry site. The needle was then guided toward the transverse process using an out-of-plane method using a blocking needle (Stimuplex® Ultra 360® 22G 80 mm, Melsungen, Germany). After bone contact was achieved, facial hydrodissection was observed with 1-2 ml of saline solution to verify the correct injection site. 20 ml of 0.25% bupivacaine was injected into the plane. The distribution of the drug was visualised by USG.
| Study group | Role | What they receive |
|---|---|---|
| ESPB + group | Active comparator | the patients who received ESPB Receives: Procedure: Erector spinae plane block (ESPB) |
| ESPB - group | No intervention | the patients who not received ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tramadol consumption in the first 24 hours after surgery
Effect of ESPB on total tramadol consumption in the first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (3)
Postoperative Resting Numerical Rating Scale (NRS) scores
Postoperative resting Numerical Rating Scale (NRS) scores in 72 hours (minimum 0 - maximum 10)
Measured: 72 hours
Postoperative Deep Breathing/Coughing Numerical Rating Scale (NRS) scores
Postoperative deep breathing/coughing Numerical Rating Scale (NRS) scores in 72 hours (minimum 0 - maximum 10)
Measured: 72 hours
Postoperative nausea and vomiting
Evaluation of the frequency and severity of postoperative nausea and vomiting between the two groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Sep 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
- Investigators
- Burcu İzgi Duman, MD, Principal investigator, Basaksehir Cam ve Sakura State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185607
- Sponsor's protocol ID
- 2023-485
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identifying, formatting and transferring data into a standardized, usable electronic format can be time-consuming.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Erector Spinae Plane Block in Patients Undergoing Robotic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07185607
- Acronym / sponsor ID
- 2023-485
- Conditions
- Erector Spinae Plane Block, Robotic Surgery, Postoperative Pain Management, Colorectal Surgery
- Keywords
- erector spinae plane block, robotic surgery, postoperative pain management, colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 22 Sep 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.
The primary objective of this study is to demonstrate whether the Erector Spinae Plane Block provides effective analgesia in patients undergoing robotic colorectal surgery and whether it contributes positively to the postoperative process.
With the advantages of ultrasound in recent years, the application of regional anesthesia methods such as trunk and peripheral nerve blocks has become a crucial component of multimodal analgesia strategies in postoperative pain management. Among regional techniques, the erector spinae plane block, in particular, has been shown to provide effective analgesia after numerous surgeries in recent years and is increasingly being used. Because the erector spinae plane block provides effective analgesia in a wide range of thoracic and abdominal surgeries, such as thoracotomy, cholecystectomy, and bariatric surgery, and because it is a simple and safe block, it is gaining increasing acceptance in daily practice for the treatment of chronic and acute pain. The aim of postoperative analgesia management is to provide effective analgesia by using multimodal techniques, thus reducing opioid consumption and related complications, providing early mobilization and shorter hospital stay, and increasing patient comfort.
Detailed description
Once the effectiveness of the Erector Spinae Plane Block has been demonstrated in patients undergoing robotic colorectal surgery, it will be implemented routinely in our clinic, aiming to reduce postoperative narcotic analgesic consumption, protect patients from narcotic analgesic side effects, facilitate early patient mobilization, shorten hospital stays, and increase patient comfort.
Because no additional procedures or medications were administered to patients outside of routine procedures, no additional risks are anticipated.
Pain is a subjective symptom, and to minimize interpatient variability, it will be assessed using the Numeric Rating Scale (NRS), a standardized scale.
The Postoperative Nausea Vomiting Impact Scale Score will be used to assess postoperative nausea and vomiting.
All volunteers participating in the study, whether or not a block is applied, will receive intravenous analgesia postoperatively using patient-controlled analgesia devices containing 4 mg/ml tramadol, with no basal infusion, a lockout time of 30 minutes, a bolus dose of 3 ml, and no baseline infusion. Data on the time of patients' first analgesic needs, the total number of analgesic requests and at what time, and the total tramadol dose administered will be obtained and recorded from the PCA devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB + group | Active comparator | Procedure: Erector spinae plane block (ESPB)the patients who received ESPB |
| ESPB - group | No intervention | –the patients who not received ESPB |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- Male and female gender
- Ages 18-75
- Malignant patients undergoing robotic colorectal surgery
Key exclusion criteria (5 listed)
- ASA>III
- Coagulopathy
- Morbid obesity
- History of chronic analgesic use
- Data loss due to limited cooperation during NRS follow-up
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 block (ESPB)Erector spinae plane block is not a drug or a device. It is a regional method for anesthesia/analgesia. Before block application, patients were placed in a sitting position. A preliminary examination with a high-frequency linear probe was performed to identify the application site. Sterile conditions were then established. An ultrasound probe was longitudinally placed approximately 2 cm lateral to the T11 spinous process. The transverse process was visualized. 1 ml of 2% lidocaine was applied to the estimated needle entry site. The needle was then guided toward the transverse process using an out-of-plane method using a blocking needle (Stimuplex® Ultra 360® 22G 80 mm, Melsungen, Germany). After bone contact was achieved, facial hydrodissection was observed with 1-2 ml of saline solution to verify the correct injection site. 20 ml of 0.25% bupivacaine was injected into the plane. The distribution of the drug was visualised by USG. | Procedure or surgery | ESPB + group |
Primary outcome
Total tramadol consumption in the first 24 hours after surgery
Time frame: 24 hours
Effect of ESPB on total tramadol consumption in the first 24 hours after surgery
3 secondary outcomes
Postoperative Resting Numerical Rating Scale (NRS) scores
Time frame: 72 hours
Postoperative Deep Breathing/Coughing Numerical Rating Scale (NRS) scores
Time frame: 72 hours
Postoperative nausea and vomiting
Time frame: 24 hours
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 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. De-identifying, formatting and transferring data into a standardized, usable electronic format can be time-consuming.
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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.
Burcu İzgi Duman, MD principal investigator
Basaksehir Cam ve Sakura State 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 Erector spinae plane block (ESPB) in people with Erector Spinae Plane Block and Robotic Surgery, run by Istanbul Saglik Bilimleri 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 5 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 22 Sep 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?
Total tramadol consumption in the first 24 hours after surgery (time frame: 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 22 Sep 2025.