NCT07297433

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

December 9, 2025

Last Update Submit

May 24, 2026

Conditions

Keywords

Erector spinae plane blockLaparoscopic surgeryNear-infrared spectroscopyPostoperative kidney injuryColorectal cancers

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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.

    During the operation period

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Şehir Hastanesi

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Günhan Gökahmetoğlu

    Kayseri City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will be randomized using the sealed envelope method. The anesthesiologist performing the procedure will be fixed, and the person keeping records will always be another anesthesiologist.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant doktor

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

January 5, 2025

Primary Completion

April 12, 2026

Study Completion

April 15, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations