Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy

Postoperative Pain Clinical Trial

Official title:

Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387095
• Other study ID #: 2024/01/756
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: omer savluk
• Phone: +905056877440
• Email: dromersavluk[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2025
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 1. no block
After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.
• 2. superficial parasternal block
After induction, the patient will undergo an ultrasound-guided superficial parasternal plan block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.
• 3. deep parasternal block
After induction, the patient will undergo an ultrasound-guided deep parasternal plane block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.

Locations

Country	Name	City	State
Turkey	Kosuyolu High Education and Training Hospital	Istanbul	Kartal

Sponsors (1)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative chronic pain	Determination the effect of parasternal blocks on the incidence for chronic pain at 6 months postoperative period in cardiac surgery. The s-lanss scores of the patients at the 6th postoperative month will be evaluated. The range of the questionnaire is 0-24 and patients with a score above 12 will be considered to have neuropathic pain.	6 months
Secondary	postoperative 24 hours acute pain	postoperative 24 hours pain of the patients will be evaluated with VAS (visual analogue scale). analgesic needs of the patients in the first 24 hours postoperatively will be calculated as morphine equivalent dose using PCA device. At the end of the 24th hour, BPI (brief pain index) will be evaluated. additional analgesic needs of the patients (NSAID, narcotic), if any, will be recorded. it will be evaluated whether there is a significant difference between the VAS scores, analgesic needs and BPI scores in the first 24 hours pain according to the groups.	24 hours
Secondary	extubation time	Extubation time (defined as the time from admission to intensive care unit until extubation) will be evaluated for differences between the groups.the control group	24 hours
Secondary	icu time	The study will look at whether intensive care and hospital discharge times differ between the groups.	7 days