Comparison of the Efficacy of Erector Spina Plane Block and Thoracic Epidural Analgesia After Thoracotomy

NCT ID: NCT05402917

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-01-01

Brief Summary

In patients who undergoing lobectomy with thoracotomy incision, the effectiveness of erector spina plane block in post-operative analgesia management is at least as much as thoracic epidural anesthesia.

Detailed Description

Observational recording of the data was planned by dividing the patients who met the internal criteria of the study and whose written and verbal consents were obtained for the study, into two groups as the patients applied ESPB or TEA. ESPB and TEA are applied to patients in our clinic depending on the preference of the physician. The routine procedures in ESPB and TEA are described in groups part. For this study, no procedure or intervention other than this routine will be performed, and the research will be conducted observationally.

Anesthesia induction for both groups will be performed with standard monitors, electrocardiogram, peripheral oxygen saturation probe and non-invasive automatic blood pressure/invasive arterial monitoring in the operating room. Anesthesia induction will be performed with 2 mg/kg propofol, 2 mcg/kg fentanyl and 0.6 mg/kg rocuronium with 1.5 mg/kg IV lidocaine, followed by double lumen endotracheal intubation and positive pressure mechanical ventilation with controlled positive 50% inspired oxygen. Ventilation parameters will be adjusted to keep end-tidal carbon dioxide around 35 mmHg. Anesthesia will be maintained with end-tidal sevoflurane 0.7-1.5 minimum alveolar concentration (adjusted for hemodynamics) 0.15 mg/kg rocuronium and 0.05-0.2 mcg/kg/min remifentanil (adjusted for hemodynamics). Acetaminophen (1 g paracetamol) IV will be administered to all patients 30 minutes before the end of surgery.

Blood pressure, peripheral oxygen saturation, heart rate, end-pulmonary carbon dioxide value and mac value of the patients will be recorded before and after block application, before and after anesthesia induction, every 15 minutes in the first hour and every 30 minutes after the first hour. Patients will be extubated with 0.03 mg/kg atropine and 0.07 mg/kg neostigmine at the end of surgery. Hemodynamic and resting Visual Analogue Scale (VAS) values for both groups taken to the post-operative intensive care unit will be recorded by nurse or anesthesia assistant at 0,2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit. In combination with the numerical pain scale, the Wong-Baker face pain scale (FS) will be used for the postoperative pain assessment of the patient. The pain assessment form will have six faces representing pain along with numbers 0 to 10, with 0 for no pain and 10 for being unbearable pain. Post-operative nausea, vomiting and any complications related to the block will be reported. Patients in the two groups will be evaluated with the VAS score for the pain they describe and record; VAS 0-4 will be classified as mild, VAS 5-7 as moderate, VAS 8-10 as severe pain. In patients with VAS >4, additional analgesia will be given with IV non-steroidal anti-inflammatory drugs (20 mg tenoxicam); after 30 minutes, VAS scoring will be evaluated again and IV tramadol 2 mg/kg (not to exceed a maximum of 100 mg once and not to exceed a maximum of 400 mg daily) will be administered in addition to patients with VAS>4. Additional analgesia amounts and hours used will be recorded.

Conditions

Pain, Postoperative

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Thoracic Epidural Analgesia (TEA)

For patients undergoing TEA is done under general anesthesia after surgery procedure.Once the catheter is secured, a bolus dose of 15 ml of 0.25% bupivacaine will be administered as an epidural injection through the catheter, followed by a continuous infusion of 0.125% bupivacaine at a rate of 0.1 mL/kg/h for the postoperative 24-hour period.

No interventions assigned to this group

Erector Spina Plan Block (ESPB)

For patients undergoing ESPB is done under general anesthesia after surgery procedure.A bolus dose of 15 mL of 0.25% bupivacaine will be administered from the inserted catheter. Subsequently, 0.125% bupivacaine will be given continuously at a rate of 0.1 mL/kg/h for up to 24 hours post-operatively.

Erector Spinae Plane Block

Intervention Type: PROCEDURE

Interfascial plane (area) blocks are blocks in which the local anesthetic agent is injected into the potential area between the two fasciae. The ESPB we used in our study is a member of interfascial plane blocks. The erector is applied between the spinal muscle and the transverse process, spreading the drug from the injection site to both cranial and caudal. Unlike other defined interfascial plane blocks, ESPB can show paraspinal block characteristics since the injection site is above the transverse process.

Interventions

Erector Spinae Plane Block

Interfascial plane (area) blocks are blocks in which the local anesthetic agent is injected into the potential area between the two fasciae. The ESPB we used in our study is a member of interfascial plane blocks. The erector is applied between the spinal muscle and the transverse process, spreading the drug from the injection site to both cranial and caudal. Unlike other defined interfascial plane blocks, ESPB can show paraspinal block characteristics since the injection site is above the transverse process.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Lobectomy planned with thoracotomy incision;
• Adult aged 18-75;
• American Society of Anesthesiology(ASA) score1-3.

Exclusion Criteria

• Obesity (BMI greater than 35 kg/m2)
• Local infection at the injection site,
• Presence of known coagulopathy
• Bone or brain metastasis
• Having impaired liver or kidney function
• Patients who cannot evaluate VAS as cognitive function
• Patients who cannot use the Patient-Controlled Analgesia (PCA) pump as a -cognitive function
• History of chronic pain medication use
• Allergy to the drugs to be used in the study
• Withdrawing consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mesut Aslan

OTHER

Sponsor Role: lead

Responsible Party

Mesut Aslan

Asistant Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

espVStea

Identifier Type: -

Identifier Source: org_study_id