- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297433
Erector Spinae Plane Block in Laparoscopic Colorectal Cancer Surgery
Erector Spinae Plane Block in Laparoscopic Colorectal Cancer Surgery: Effects on Renal Blood Flow and Kidney Function
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey (Türkiye), 38080
- Kayseri Şehir Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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.
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
For 24 hours after procedure
|
|
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.
|
For 24 hours after the procedure
|
|
eGFR
Time Frame: For 24 hours after the procedure
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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
|
For 24 hours after the procedure
|
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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.
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During the operation period
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Günhan Gökahmetoğlu, Kayseri City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KayseriCH-AAR-AEK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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