Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery
ESP
Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study
3 other identifiers
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2021
CompletedStudy Start
First participant enrolled
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedAugust 4, 2021
July 1, 2021
3 months
July 31, 2021
July 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rescue analgesia
Total amount of rescue analgesic
Post-extubation 24 hours
Study Arms (2)
ESP 20 ml
ACTIVE COMPARATORUltrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine
ESP 30 ml
ACTIVE COMPARATORUltrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine
Interventions
Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery
You may not qualify if:
- chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
July 31, 2021
First Posted
August 4, 2021
Study Start
August 2, 2021
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
August 4, 2021
Record last verified: 2021-07