Back to resultsUltrasound-Guided Erector Spinae Plan Block for Colorectal Surgery
Primary Purpose
Colorectal Cancer, Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine Hcl 0.25% ESP block
Bupivacaine Hcl 0.25% infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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
Sites / Locations
- Ataturk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group ESPB
Group Infiltration
Arm Description
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side
Wound infiltration with 20 ml %0.25 bupivacaine
Outcomes
Primary Outcome Measures
Opioid Consumption
Opioid consumption postroperative period
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04313764
Brief Title
Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery
Official Title
The Comparison of the Erector Spinae Plane Block and Wound Infiltration on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2020 (Anticipated)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group ESPB
Arm Type
Active Comparator
Arm Description
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side
Arm Title
Group Infiltration
Arm Type
Active Comparator
Arm Description
Wound infiltration with 20 ml %0.25 bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.25% ESP block
Intervention Description
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.25% infiltration
Intervention Description
Wound infiltration with 20 ml %0.25 bupivacaine
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Opioid consumption postroperative period
Time Frame
Postoperative first 24 hours
Secondary Outcome Measure Information:
Title
Visual Analog Pain Score
Description
Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Time Frame
Postoperative first 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İrem Ates, MD
Phone
00905327401258
Email
driremates@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ahiskalioglu, MD
Phone
00905444424831
Email
aliahiskalioglu@hotmail.com
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Murat Yayik, MD
Phone
00905544259287
Email
m_yayik@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
29381824
Citation
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.
Results Reference
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PubMed Identifier
31695476
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.
Results Reference
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Learn more about this trial
Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery
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