Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: a Randomized, Double-blind, Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called Pecto-Intercostal Fascial Block \[PIFB\]) with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult male or female patients aged \> 18

• Undergoing primary cardiac surgery requiring sternotomy

• Able to provide a signed written informed consent

• Able to speak, read, and write in English

• American Society of Anesthesiologists (ASA) physical status I-IV

Locations
United States
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Contact Information
Primary
Alberto A Uribe
alberto.uribe@osumc.edu
6142930775
Backup
Jeremy Reeves
jeremy.reeves@osumc.edu
6142933559
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 84
Treatments
Active_comparator: Pecto-intercostal fascial block
Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.
Placebo_comparator: Placebo
Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov

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