Bilateral Erector Spina Block Versus Parasternal Block in Adult Heart Surgery

NCT04090099 | Completed

• 1 other identifier: 2019/14-08
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block may provide adequate analgesia for median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median sternotomy incision and mediastinal tube regions are the major source of pain in patients undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is effective in providing early postoperative analgesia and reducing opioid requirements and therefore has positive effects on healing. This simple and fast technique can be used even for anticoagulated patients.

Conditions

Morphine Consumption; Pain, Postoperative

Keywords

Erector Spinae Block, Parasternal block, Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Morphine consumption by PCA

  Morphine consumption used in case of pain

  Change from baseline 1 , 3, 6, 12 and 24 hours after extubation

Secondary Outcomes (3)

• Change Pain Scores

  Time Frame: 1 hour,3 hours, 6 hours, 12 hours, 24 hours after the extubation

• Change Blood Gas

  Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,

• Blood Pressure

  Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,

Study Arms (3)

Group C

NO INTERVENTION

PCA (Patient controlled analgesia) and morphine consumption will be monitored in the postoperative period.

Group ES (Erector Spina Plane)

ACTIVE COMPARATOR

A high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle. A dose of 0.25% bupivacaine will be injected which is shown to spread both above and below the T5 level. The same process will be implemented on the other side.

Other: Erector spina plane block

Group PS (Para Sternal Block)

ACTIVE COMPARATOR

Before the wire is inserted into the sternum, the sternotomy and mediastinal tube regions will be infiltrated with a mixture of bupivacaine and saline.

Other: Erector spina plane block

Interventions

Erector spina plane block OTHER

While the patient is in the sitting position, an area containing 2 cm lateral of the T5 spinous process will be cleaned with povidone iodine. A high frequency ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle.

Group ES (Erector Spina Plane); Group PS (Para Sternal Block)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and / or female patients
• Aged 18-65 years
• Patients who will have coronary artery surgery under cardiopulmonary baypass (changing one, two and three vessels) with normal left ventricular function,
• Valve diseases with normal left ventricular function,
• ASD (Atrial Septal Defect) cases for atrial septal defect closure
• Patients with valve + CABG without left ventricular dysfunction will be included in the study.
• Ejection- Fraction\> 50-55

You may not qualify if:

• Emergency and repeat heart surgery cases
• Advanced left coronary artery disease and left ventricular dysfunction
• Receiving preoperative inotropic support therapy,
• With mitral stenosis with atrial tombus,
• With low cardiac out put syndrome,
• Need intra-aortic balloon pump during surgery,
• Bleeding and coagulation disorder,
• Liver and kidney dysfunction,
• Patients with uncontrolled diabetes mellitus and coronary artery pulmonary disease,
• Opioid, analgesic and bupivacaine allergy,
• Patients with atrial fbrilation using anticoagulants
• Patients with cognitive dysfunction
• Patients who do not want to participate in the study

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Kahramanmaras Sutcu Imam Univercity Faculty of edicine

Kahramanmaraş, Onikişubat, 251/A 46040, Turkey (Türkiye)

Location

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, Onikişubat, 251/A 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• yavuz orak, md

  Kahramanmaraş Sutcu Imam University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: September 17, 2019
• Primary Completion: October 14, 2021
• Study Completion: May 15, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)