Clinical trial NCT06387095: Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy
Official title: Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
parasternal blocks
chronic pain
acute pain
cabg
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.

Detailed description: The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).

Eligibility criteria: Inclusion Criteria:

* Performing median sternotomy
* Elective case
* Over 18 years of age; under 80 years of age
* ASA II-III patients

Exclusion Criteria:

* Emergency cases
* Patients undergoing minimally invasive surgery
* Patients with a history of opioid use in the last 30 days
* Redo cases
* Patients with left ventricular ejection fraction less than 30%
* Patients with severe hepatic or renal insufficiency
* Patients with chronic pain before surgery (migraine, fibromyalgia)

Primary outcomes:
measure: postoperative chronic pain
timeFrame: 6 months
Secondary outcomes:
measure: postoperative 24 hours acute pain
timeFrame: 24 hours
measure: extubation time
timeFrame: 24 hours
measure: icu time
timeFrame: 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kosuyolu High Education and Training Hospital
state: Kartal
Study officials:
affiliation: kosuyolu high education and training center
name: munire deniz
role: STUDY_DIRECTOR
References: