Kolon KanseriNCT07297433
Erector Spinae Plane Block in Laparoscopic Colorectal Cancer Surgery
A study testing Erector Spinae Plane Block in people with Kolon Kanseri, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our study will compare patients who underwent laparoscopic surgery for colorectal cancer with and without Erector Spinae Plane Block in terms of renal blood flow and renal function tests. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kolon Kanseri
- What is being tested?
- Erector Spinae Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 35-75 years old
- Colorectal cancer surgery must be planned by a physician
- No infection in the injection site
- No history of any disease related to clotting or bleeding time
- The patient must be a volunteer
- No history of local anesthetic allergy
Who cannot join
- Being under 18 years of age
- Having a systemic infection or infection at the injection site
- Having any disease related to bleeding time and clotting
- Having a history of local anesthetic allergy
- Patient refusal (ESPB for analgesic purposes)
- Patients with a Body Mass Index (BMI) of 30 or above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block in Laparoscopic Colorectal Cancer Surgery: Effects on Renal Blood Flow and Kidney Function
Our study will compare patients who underwent laparoscopic surgery for colorectal cancer with and without Erector Spinae Plane Block in terms of renal blood flow and renal function tests. In our study, which will be conducted by dividing patients into two groups, the investigators aim to demonstrate the effects of the erector spinae plane block on renal physiology by simultaneously monitoring renal blood flow during the intraoperative period using near-infrared spectroscopy and monitoring renal function in the postoperative period using NGAL, serum creatinine, and eGFR.
Read the detailed description
Our study comparing patients who did and did not undergo ESBP in terms of renal blood flow and renal function tests during laparoscopic surgeries for colorectal cancer is planned to be conducted at Kayseri City Hospital with volunteer patients.
The erector spinae plane block (ESP) is a block that is easy to perform with ultrasound (USG) guidance and has a relatively low risk of mechanical complications. It has quickly become popular and is used in various indications in anesthesiology and resuscitation clinics.
The total number of volunteers expected to participate in this study is 60. Patients will be randomly assigned to two groups using a sealed envelope method. The number of volunteers determined for each group is 30.
Patients will be interviewed before the operation and informed about the operation and the procedure to be performed. After reading and approving the informed consent form, patients to be included in the study will be divided into two groups using the sealed envelope method. Group 1 will receive ESP block, while Group 2 will be the control group and will not receive any block.
All patients will be monitored throughout the operation using invasive blood pressure, ECG, and pulse oximetry. Following preoxygenation, induction will be administered with intravenous propofol (2 mg/kg), fentanyl 1 µg/kg, and rocuronium (0.6 mg/kg) injections. After tracheal intubation, an arterial catheter will be placed in the radial artery to continuously monitor blood pressure. Anesthesia maintenance will be achieved with inhaled sevoflurane and intravenous remifentanil infusion. After induction, patients will be placed in the left-right lateral decubitus position, and bilateral blocks will be performed with ultrasound guidance.
Group 1: ESP block, 0.5% bupivacaine 0.2-0.4 ml/kg will be administered. Group 2: Patient group without block.
After ESBP application, the 'Near infrared spectroscopy' device will be placed on the bilateral 9-10th posterior costal region (flank region) of the patients in a manner suitable for observing renal blood flow. Monitoring will be performed throughout the operation and recorded on the follow-up form. N-GAL, serum creatinine, and eGFR values will be measured in both groups during the preoperative and postoperative periods (at 2, 6, and 24 hours).
Once the expected number of patients is reached, the data obtained will be statistically evaluated and recorded.
After the data is collected, it will be processed for statistical evaluation.
- Conditions
- Kolon Kanseri
- Being tested
- Erector Spinae Plane Block
- Keywords
- Erector spinae plane block, Laparoscopic surgery, Near-infrared spectroscopy, Postoperative kidney injury, Colorectal cancers
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
The erector spinae plane block (ESP) is a block that is easy to perform with ultrasound (USG) guidance and has a relatively low risk of mechanical complications. It has quickly become popular and is used in various indications in anesthesiology and resuscitation clinics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients will be informed about the operation and the procedure to be performed during a preoperative consultation. Patients included in the study will be taken to the operating room after reading and signing the informed consent form. Bilateral erector spinae plane block will be administered to patients in this group prior to surgery. Renal blood flow will be monitored using NIRS. Postoperative period: NGAL, serum creatinine, and eGFR values will be measured at 2, 6, and 24 hours. Receives: Other: Erector Spinae Plane Block |
| Control group | No intervention | Patients will be interviewed before surgery and informed about the surgery and the procedure to be performed. Patients to be included in the study will be taken to the operating room after reading and approving the informed consent form. Patients in this group will not undergo erector spinae plane block. Renal blood flow will be monitored using NIRS. In the postoperative period, NGAL, serum creatinine, and eGFR values will be measured at 2, 6, and 24 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil gelatinase-associated lipocalin (NGAL)
Neutrophil gelatinase-associated lipocalin (NGAL) is a small, stable protein synthesized by various epithelia, including neutrophils and renal proximal tubules. Its dramatic increase in urine following kidney injury has made NGAL a useful biomarker for kidney damage today. According to the catalog information, serum NGAL kits can measure between 15-1300 ng/ml. Values above 150 ng/ml are considered positive. Results above 170 ng/ml in adult patients and above 100-135 ng/ml in pediatric patients are considered positive.
Measured: For 24 hours after procedure
Serum Kreatinin
In adults, the normal range for creatinine is generally 0.7 to 1.2 milligrams per deciliter (mg/dL) for men and 0.5 to 0.9 mg/dL for women. Reference ranges may vary between laboratories.
Measured: For 24 hours after the procedure
eGFR
EGFR>90: Minimal kidney damage based on normal GFR or urine test results EGFR between 60-89: Mild decrease in GFR EGFR between 30-59: Moderate decrease in GFR EGFR between 15-29: Severe decrease in GFR EGFR<15: Kidney failure
Measured: For 24 hours after the procedure
Near-Infrared Spectroscopy (NIRS)
Near-Infrared Spectroscopy (NIRS) is a non-invasive method for assessing tissue oxygenation. It is increasingly used to monitor renal perfusion, particularly in critically ill patients, during surgery, and in intensive care units, where it is important for evaluating kidney oxygenation. NIRS measures the absorption of near-infrared light (700-1000 nm) sent to the tissue by the oxygenated (HbO₂) and deoxygenated (Hb) forms of hemoglobin. In laparoscopic surgeries, renal blood flow may decrease without a drop in blood pressure, and acute kidney injury may occur in the postoperative period. NIRS is used to predict this condition.
Measured: During the operation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start5 Jan 2025
- Primary completion12 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 Kolon KanseriStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Arif Enes Koyuncu, Kayseri City Hospital
- Investigators
- Günhan Gökahmetoğlu, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297433
- Sponsor's protocol ID
- KayseriCH-AAR-AEK-01
- Status last verified
- May 2026
- First submitted
- 9 Dec 2025
- Last updated
- 27 May 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block in Laparoscopic Colorectal Cancer Surgery: Effects on Renal Blood Flow and Kidney Function
- ClinicalTrials.gov ID
- NCT07297433
- Acronym / sponsor ID
- KayseriCH-AAR-AEK-01
- Conditions
- Kolon Kanseri
- Keywords
- Erector spinae plane block, Laparoscopic surgery, Near-infrared spectroscopy, Postoperative kidney injury, Colorectal cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 12 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 22 Dec 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.
Our study will compare patients who underwent laparoscopic surgery for colorectal cancer with and without Erector Spinae Plane Block in terms of renal blood flow and renal function tests. In our study, which will be conducted by dividing patients into two groups, the investigators aim to demonstrate the effects of the erector spinae plane block on renal physiology by simultaneously monitoring renal blood flow during the intraoperative period using near-infrared spectroscopy and monitoring renal function in the postoperative period using NGAL, serum creatinine, and eGFR.
Detailed description
Our study comparing patients who did and did not undergo ESBP in terms of renal blood flow and renal function tests during laparoscopic surgeries for colorectal cancer is planned to be conducted at Kayseri City Hospital with volunteer patients.
The erector spinae plane block (ESP) is a block that is easy to perform with ultrasound (USG) guidance and has a relatively low risk of mechanical complications. It has quickly become popular and is used in various indications in anesthesiology and resuscitation clinics.
The total number of volunteers expected to participate in this study is 60. Patients will be randomly assigned to two groups using a sealed envelope method. The number of volunteers determined for each group is 30.
Patients will be interviewed before the operation and informed about the operation and the procedure to be performed. After reading and approving the informed consent form, patients to be included in the study will be divided into two groups using the sealed envelope method. Group 1 will receive ESP block, while Group 2 will be the control group and will not receive any block.
All patients will be monitored throughout the operation using invasive blood pressure, ECG, and pulse oximetry. Following preoxygenation, induction will be administered with intravenous propofol (2 mg/kg), fentanyl 1 µg/kg, and rocuronium (0.6 mg/kg) injections. After tracheal intubation, an arterial catheter will be placed in the radial artery to continuously monitor blood pressure. Anesthesia maintenance will be achieved with inhaled sevoflurane and intravenous remifentanil infusion. After induction, patients will be placed in the left-right lateral decubitus position, and bilateral blocks will be performed with ultrasound guidance.
Group 1: ESP block, 0.5% bupivacaine 0.2-0.4 ml/kg will be administered. Group 2: Patient group without block.
After ESBP application, the 'Near infrared spectroscopy' device will be placed on the bilateral 9-10th posterior costal region (flank region) of the patients in a manner suitable for observing renal blood flow. Monitoring will be performed throughout the operation and recorded on the follow-up form. N-GAL, serum creatinine, and eGFR values will be measured in both groups during the preoperative and postoperative periods (at 2, 6, and 24 hours).
Once the expected number of patients is reached, the data obtained will be statistically evaluated and recorded.
After the data is collected, it will be processed for statistical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Erector Spinae Plane BlockPatients will be informed about the operation and the procedure to be performed during a preoperative consultation. Patients included in the study will be taken to the operating room after reading and signing the informed consent form. Bilateral erector spinae plane block will be administered to patients in this group prior to surgery. Renal blood flow will be monitored using NIRS. Postoperative period: NGAL, serum creatinine, and eGFR values will be measured at 2, 6, and 24 hours. |
| Control group | No intervention | –Patients will be interviewed before surgery and informed about the surgery and the procedure to be performed. Patients to be included in the study will be taken to the operating room after reading and approving the informed consent form. Patients in this group will not undergo erector spinae plane block. Renal blood flow will be monitored using NIRS. In the postoperative period, NGAL, serum creatinine, and eGFR values will be measured at 2, 6, and 24 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 35-75 years old
- Colorectal cancer surgery must be planned by a physician
- No infection in the injection site
- No history of any disease related to clotting or bleeding time
- The patient must be a volunteer
Key exclusion criteria (6 listed)
- Being under 18 years of age
- Having a systemic infection or infection at the injection site
- Having any disease related to bleeding time and clotting
- Having a history of local anesthetic allergy
- Patient refusal (ESPB for analgesic purposes)
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 BlockThe erector spinae plane block (ESP) is a block that is easy to perform with ultrasound (USG) guidance and has a relatively low risk of mechanical complications. It has quickly become popular and is used in various indications in anesthesiology and resuscitation clinics. | Other | Intervention group |
Primary outcome
Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: For 24 hours after procedure
Neutrophil gelatinase-associated lipocalin (NGAL) is a small, stable protein synthesized by various epithelia, including neutrophils and renal proximal tubules. Its dramatic increase in urine following kidney injury has made NGAL a useful biomarker for kidney damage today. According to the catalog information, serum NGAL kits can measure between 15-1300 ng/ml. Values above 150 ng/ml are considered positive. Results above 170 ng/ml in adult patients and above 100-135 ng/ml in pediatric patients are considered positive.
Serum Kreatinin
Time frame: For 24 hours after the procedure
In adults, the normal range for creatinine is generally 0.7 to 1.2 milligrams per deciliter (mg/dL) for men and 0.5 to 0.9 mg/dL for women. Reference ranges may vary between laboratories.
eGFR
Time frame: For 24 hours after the procedure
EGFR>90: Minimal kidney damage based on normal GFR or urine test results EGFR between 60-89: Mild decrease in GFR EGFR between 30-59: Moderate decrease in GFR EGFR between 15-29: Severe decrease in GFR EGFR<15: Kidney failure
Near-Infrared Spectroscopy (NIRS)
Time frame: During the operation period
Near-Infrared Spectroscopy (NIRS) is a non-invasive method for assessing tissue oxygenation. It is increasingly used to monitor renal perfusion, particularly in critically ill patients, during surgery, and in intensive care units, where it is important for evaluating kidney oxygenation. NIRS measures the absorption of near-infrared light (700-1000 nm) sent to the tissue by the oxygenated (HbO₂) and deoxygenated (Hb) forms of hemoglobin. In laparoscopic surgeries, renal blood flow may decrease without a drop in blood pressure, and acute kidney injury may occur in the postoperative period. NIRS is used to predict this condition.
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 May 2026.
- Individual participant dataSharing planned: No
Related trials for Kolon Kanseri
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.
Günhan Gökahmetoğlu principal investigator
Kayseri 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 Erector Spinae Plane Block in people with Kolon Kanseri, run by Kayseri City Hospital 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 6 inclusion and 6 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 May 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?
Neutrophil gelatinase-associated lipocalin (NGAL) (time frame: For 24 hours after procedure). The study lists 4 primary outcomes in all. 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 May 2026.