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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04313764
Other study ID # ESP Colorectal Surgery
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 18, 2020
Est. completion date August 15, 2020

Study information

Verified date June 2020
Source Ataturk University
Contact Irem Ates, MD
Phone 00905327401258
Email driremates@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date August 15, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Hcl 0.25% ESP block
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side
Bupivacaine Hcl 0.25% infiltration
Wound infiltration with 20 ml %0.25 bupivacaine

Locations

Country Name City State
Turkey Ataturk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hain E, Maggiori L, Prost À 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid Consumption Opioid consumption postroperative period Postoperative first 24 hours
Secondary 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
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