The Effect of Bilateral Erector Spina Plane Block on Postoperative Pain in Adult Cardiac Surgery.

NCT04906239 | Completed

• 1 other identifier: 2020/18-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Failure to adequately prevent pain after heart surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. Aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spinae Block, a new block.

Conditions

Postoperative Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Morphine consumption by PCA (Patient Control Analgesia)

  Morphine consumption used in case of pain

  The change from baseline in the postoperative period 1, 4, 12 and 24 hours after extübation

Secondary Outcomes (1)

• Pain (VAS Score)

  Change From Baseline of VAS Score at 1, 4, 12 and 24 hours after being extubated will be recorded.

Study Arms (2)

Group ESP

ACTIVE COMPARATOR

While the patient is in a sitting position, A ultrasound probe covered with a sterile sheath will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After the T 4-5 transverse process and the erector spinae muscle above it are shown, a quincke-type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal with the entrance made using the in-plane technique. When the transverse process is touched, the needle will be pulled out and a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.The same procedure will be repeated on the contralateral side of the T5 spinous process and half of the remaining bupivacaine dose will be injected. The total volume of bupivacaine injected on both sides will be 20 mL.

Procedure: Erector Spinae Plane Block

Group Control

NO INTERVENTION

No block will be made to the control group. After extubation, 1mg / kg tramadol will be applied routinely to both groups, and PCA (Patient Control Analgesia) and morphine consumption and VAS (visual analog scale) pain scores of both groups will be evaluated and recorded at the 1st, 4th, 12th and 24th hour. When VAS is 3, patients will be advised to press the PCA device.

Interventions

Erector Spinae Plane Block PROCEDURE

A high-frequency ultrasound linear probe, covered with a sterile sheath, will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After showing the T 4-5 transverse process and the erector spinae muscle on top of it, a 22-gauge, 80 mm insulated quincke type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal, using the in-plane technique. When the transverse process is touched, the needle will be pulled out and after a negative aspiration test with 0.5 mL of normal saline and after the demonstration of a hypo-echogenic image and hydro dissection, a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.

Group ESP

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 will be included in the study.
• Normal left ventricular function (alternating one, two and three vessels).
• coronary artery patients scheduled for elective coronary artery surgery under cardiopulmonary bypass,
• Valvular diseases planned for elective valve replacement with normal left ventricular function, ASD (Atrial Septal Defect) cases for atrial septal defect closure, and patients without left ventricular dysfunction (E / F≥ 50-55%) elective valve + CABG will be included in the study.

You may not qualify if:

• Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
• Patients who have had myocardial infarction within the past month
• Recurrent cardiovascular surgery
• Off-pump coronary artery bypass surgery (OPCAB)
• Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
• Patients with chronic renal failure, liver disease, active infection
• Patients older than 80 years and smaller than 18 years
• Patients with coagulation disorders

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, 46040, Turkey (Türkiye)

Location

Yavuz Orak

Kahramanmaraş, 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, PhD

  Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Bölümü

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 28, 2021
• Study Start: June 1, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)