Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery

NCT ID: NCT04313764

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2020-08-15

Brief Summary

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.

Conditions

Colorectal Cancer; Postoperative Pain

Study Design

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

Study Groups

Group ESPB

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hcl 0.25% ESP block

Intervention Type: DRUG

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Group Infiltration

Wound infiltration with 20 ml %0.25 bupivacaine

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hcl 0.25% infiltration

Intervention Type: DRUG

Wound infiltration with 20 ml %0.25 bupivacaine

Interventions

Bupivacaine Hcl 0.25% ESP block

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Intervention Type: DRUG

Bupivacaine Hcl 0.25% infiltration

Wound infiltration with 20 ml %0.25 bupivacaine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Murat Yayik

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İrem Ates, MD

Role: CONTACT

driremates@hotmail.com

00905327401258

Ali Ahiskalioglu, MD

Role: CONTACT

aliahiskalioglu@hotmail.com

00905444424831

Facility Contacts

Ahmet Murat Yayik, MD

Role: primary

m_yayik@hotmail.com

00905544259287

References

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.

Reference Type: BACKGROUND

PMID: 29381824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31695476 (View on PubMed)

Other Identifiers

ESP Colorectal Surgery

Identifier Type: -

Identifier Source: org_study_id