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

NCT07185607 | Completed

• 1 other identifier: 2023-485
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

erector spinae plane block; robotic surgery; postoperative pain management; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Total tramadol consumption in the first 24 hours after surgery

  Effect of ESPB on total tramadol consumption in the first 24 hours after surgery

  24 hours

Secondary Outcomes (3)

• Postoperative Resting Numerical Rating Scale (NRS) scores

  72 hours

• Postoperative Deep Breathing/Coughing Numerical Rating Scale (NRS) scores

  72 hours

• Postoperative nausea and vomiting

  24 hours

Study Arms (2)

ESPB + group

ACTIVE COMPARATOR

the patients who received ESPB

Procedure: Erector spinae plane block (ESPB)

ESPB - group

NO INTERVENTION

the patients who not received ESPB

Interventions

Erector spinae plane block (ESPB) 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

Study Officials

• Burcu İzgi Duman, MD

  Basaksehir Cam ve Sakura State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The block was performed with the patients' consent. The control group did not receive the block. Therefore, due to the nature of the procedure, the patients were not blinded. The block operator was not blinded. The primary investigator assessing the patient outcomes did not know which patients received the block and which did not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 22, 2025
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

TU (1)