Effect of the Erector Spinae Plane Block in on Robotic Colorectal Surgery

NCT ID: NCT07185607

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-09-01

Brief 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.

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.

Conditions

Erector Spinae Plane Block; Robotic Surgery; Postoperative Pain Management; Colorectal Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESPB + group

the patients who received ESPB

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block (ESPB)

Intervention Type: PROCEDURE

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.

ESPB - group

the patients who not received ESPB

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA I-III
• Male and female gender
• Ages 18-75
• Malignant patients undergoing robotic colorectal surgery

Exclusion Criteria

• ASA>III
• Coagulopathy
• Morbid obesity
• History of chronic analgesic use
• Data loss due to limited cooperation during NRS follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: lead

Responsible Party

Taner Abdullah

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu İzgi Duman, MD

Role: PRINCIPAL_INVESTIGATOR

Basaksehir Cam ve Sakura State Hospital

Locations

Basaksehir Cam ve Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-485

Identifier Type: -

Identifier Source: org_study_id