Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery

The Comparison of the Erector Spinae Plane Block and Wound Infiltration on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Colorectal Surgery

Colorectal cancer is a common and lethal disease. It still remains the third most common cause of cancer death in women and the second leading cause of death in men. Pain control is an important direction of postoperative management in malignancy surgery. Inadequate pain control increases cardiac and respiratory complications in these critical patients. Erector spinae plane (ESP) block is a recently described regional anesthesia technique that blocks the dorsal and ventral rami of the spinal nerves and the sympathetic nerve fibers. While the ESP block has been shown to provide effective postoperative analgesia after thoracic, and abdominal surgeries.

Our aim in this study was to investigate bilateral thoracic ESP block for providing successful postoperative pain management following colorectal surgery.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Colorectal Cancer
• Intervention / Treatment: Drug: Bupivacaine Hcl 0.25% ESP block; Drug: Bupivacaine Hcl 0.25% infiltration

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İrem Ates, MD; Phone Number: 00905327401258; Email: driremates@hotmail.com
• Study Contact Backup: Name: Ali Ahiskalioglu, MD; Phone Number: 00905444424831; Email: aliahiskalioglu@hotmail.com

Study Locations

• Turkey
  • Erzurum, Turkey
    • Ataturk University
    • Contact: Ahmet Murat Yayik, MD; Phone Number: 00905544259287; Email: m_yayik@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologist's physiologic state I-II-III patients undergoing Colorectal surgery

Exclusion Criteria:

• renal or hepatic insufficiency, chronic pain, patients with an allergic reaction to anesthesia and analgesia drugs to be used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group ESPB; Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side	Drug: Bupivacaine Hcl 0.25% ESP block; Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side
Active Comparator: Group Infiltration; Wound infiltration with 20 ml %0.25 bupivacaine	Drug: Bupivacaine Hcl 0.25% infiltration; Wound infiltration with 20 ml %0.25 bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Opioid consumption postroperative period	Postoperative first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Score	Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)	Postoperative first 24 hours

Collaborators and Investigators

• Sponsor: Atatürk University

Publications and helpful links

General Publications

• Hain E, Maggiori L, Prost A la Denise J, Panis Y. Transversus abdominis plane (TAP) block in laparoscopic colorectal surgery improves postoperative pain management: a meta-analysis. Colorectal Dis. 2018 Apr;20(4):279-287. doi: 10.1111/codi.14037.
• Tulgar S, Ahiskalioglu A, De Cassai A, Gurkan Y. Efficacy of bilateral erector spinae plane block in the management of pain: current insights. J Pain Res. 2019 Aug 27;12:2597-2613. doi: 10.2147/JPR.S182128. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 18, 2020
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): August 15, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ESP Colorectal Surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No