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

Not Applicable

Completed

• Conditions: Erector Spinae Plane Block; Robotic Surgery; Postoperative Pain Management; Colorectal Surgery

• Registration Number: NCT07185607
• Lead Sponsor: Istanbul Saglik Bilimleri University

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.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2025-06-01
• Status Verified: 2025-09
• Study Completion: 2025-09-01
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total tramadol consumption in the first 24 hours after surgery	24 hours	Effect of ESPB on total tramadol consumption in the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative Resting Numerical Rating Scale (NRS) scores	72 hours	Postoperative resting Numerical Rating Scale (NRS) scores in 72 hours (minimum 0 - maximum 10)
Postoperative Deep Breathing/Coughing Numerical Rating Scale (NRS) scores	72 hours	Postoperative deep breathing/coughing Numerical Rating Scale (NRS) scores in 72 hours (minimum 0 - maximum 10)
Postoperative nausea and vomiting	24 hours	Evaluation of the frequency and severity of postoperative nausea and vomiting between the two groups

Trial Locations

Locations (1)

Basaksehir Cam ve Sakura City Hospital; Istanbul, Turkey (Türkiye)