ESP: Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery
Sponsor
Ataturk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04989933
Collaborator
(none)
60
2
3
Study Details
Study Description
Brief Summary
The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.
This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study
Anticipated Study Start Date
:
Aug 2, 2021
Anticipated Primary Completion Date
:
Nov 1, 2021
Anticipated Study Completion Date
:
Nov 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ESP 20 ml Ultrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine |
Procedure: Ultrasound-guided erector spinae plane block
Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine
|
| Active Comparator: ESP 30 ml Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine |
Procedure: Ultrasound-guided erector spinae plane block
Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine
|
Outcome Measures
Primary Outcome Measures
- Rescue analgesia [Post-extubation 24 hours]
Total amount of rescue analgesic
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery
Exclusion Criteria:
- chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ataturk University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ali Ahiskalioglu,
Assoc. Prof.,
Ataturk University
ClinicalTrials.gov Identifier:
NCT04989933
Other Study ID Numbers:
- AtaturkU-AnkaraCH
- Asli Demir
- Ali Ahiskalioglu
First Posted:
Aug 4, 2021
Last Update Posted:
Aug 4, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No