Effect of ESPB and Rhomboid Block on VATS Method

Comparison of the Effect of ESPB and Rhomboid Block on Postoperative Pain and Opioid Consumption in Patients Undergoing Lobectomy With VATS Method: a Randomized Controlled Study

The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain; Complication,Postoperative; Opioid Consumption
• Intervention / Treatment: Other: regional anesthesia

Detailed Description

Video-assisted thoracic surgery (VATS); Although it causes less postoperative pain compared to traditional thoracotomy, it can still cause significant postoperative problems. Relief of postoperative pain; it eliminates the undesirable pathological effects of pain, reduces the length of hospital stay and costs. Thoracic epidural analgesia and paravertebral block are recommended for the relief of postoperative pain after thoracotomy. Bendixen et al. Because VATS is less painful; recommended less invasive regional techniques and systemic analgesics. For the relief of postoperative pain after VATS; paravertebral block, erector spina plan block (ESPB), and serratus plan block have been successfully applied. In order to provide analgesia after VATS; the most appropriate techniques or protocols need to be determined. ESPB; In 2016, Forero et al. and is used for the control of pain after many surgical procedures. ESPB has been successfully applied for the relief of postoperative pain after VATS. Elsharkawy et al. have shown that rhomboid intercostal block can be beneficial in providing adequate analgesia for both anterior and posterior hemithorax, in cadaver studies, but it is better with methods that are useful in relieving pain after VATS previously. They say more comparisons are needed. In recent studies, it has been shown that rhomboid intercostal block is effective in relieving postoperative pain in comparison with control groups. More randomized controlled studies are needed to demonstrate that rhomboid intercostal block provides effective analgesia in VATS. The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.

The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management, postoperative opioid consumption and complications in patients undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in this study. Patients with contraindications for the application of either method, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, and infection at the injection site will not be included in the study. Patients who agree to participate in the study will be randomly assigned to one of the anesthesia groups of the study, which include ESPB (elector spina plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1 and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn randomly for each patient before the procedure, and procedures will be carried out according to the group specified on the paper.

Intraoperative anesthesia management The patients in this group were on the operating table before induction of anesthesia, and in the ESPB group (Group 1), after the patients were placed in the prone position, the linear ultrasound probe was placed in the midline in the transverse plane, and spinous processes were visualized at the T5 vertebra level, and the transverse process, trapezius, latissimus dorsi and erector spina muscles were visualized on the side where VATS was planned. will be displayed. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly.

In the rhomboid intercostal block group (Group 2), after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.

Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), remifentanil 1mcg/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Anesthesia will be maintained with remifentanil infusion, with ANI > 50 and BIS < 50. Patients were given 1 g i.v. before waking up after surgery. paracetamol will be given. Measurements Perioperative clinical and demographic data of each patient will be collected: age, gender, diagnosis, operation, ASA, duration of surgery, duration of anesthesia. Intraoperatively, heart rate, blood pressure, ANI and BIS measurements will be made and recorded in all patients at 15-minute intervals. The total intraoperative opioid dose will also be recorded.

Post-awakening pain will be assessed and recorded using the visual analog scale (VAS), then patient-controlled analgesia (PCA) will be initiated, with all patients locked in 15 minutes and given 4 mg of morphine at each application by the patient. Pain assessment will be done with VAS at 6, 12, 24 and 48 hours postoperatively. In the postoperative period, the amount of morphine administered by PCA (in the first and second 24 hours) and any additional analgesics required (tramadol, paracetamol, etc.) will be recorded.

sample size In a previous study, based on the consumption of morphine equivalent in the first 24 hours (approximately 2.75 mg standard deviation) [8], it was found that 33 patients per group were required to detect the 2.5 mg difference between the two groups with 90% power and 5% alpha error. . Considering that there may be a dropout of approximately 10 percent, it is planned to include at least 35 patients in each group.

Statistical analysis In the comparison of the two groups in terms of continuous numerical variables, Student t test or Mann-Whitney U test will be used for independent samples according to distribution. Groups will be compared in terms of categorical variables using the Pearson chi-square test or the Fisher exact test. Two-way ANOVA test will be used for repeated measurements in comparison of groups in terms of the course of postoperative VAS scores and intraoperative heart rate, blood pressure, ANI, BIS variables over time. A value of p<0.05 will be accepted as an indicator of significance in the tests.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey, 34854
      • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged 18-75 years, ASA 1-2-3 who gave informed consent

Description

Inclusion Criteria:

Patients aged 18-75 years, ASA 1-2-3 who gave informed consent

Exclusion Criteria:

Patients with contraindications, known chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, taking anticoagulants, infection at the injection site

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
erector spinae plane block group; In the ESPB group, after the patients are placed in the prone position, the linear ultrasound probe will be placed in the midline in the transverse plane to visualize the spinous processes, and the transverse process, trapezius, latissimus dorsi and erector spina muscles will be visualized on the side where VATS is planned at the T5 vertebra level. With an 'in-plane' approach, using a 22 gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly.	Other: regional anesthesia; in the ESPB group, the linear ultrasound probe was placed in the erector spina muscles were visualized on the side where VATS was planned. block needle can be seen on ultrasound, the skin and erector spina muscles are passed in the cranio-caudal direction. ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly. In the rhomboid intercostal block group, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.
Rhomboid block; In the rhomboid intercostal block group, after the patients are placed in the prone position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm needle will be injected into the plan between them at the T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.	Other: regional anesthesia; in the ESPB group, the linear ultrasound probe was placed in the erector spina muscles were visualized on the side where VATS was planned. block needle can be seen on ultrasound, the skin and erector spina muscles are passed in the cranio-caudal direction. ESPB will be administered with 20 ml of 0.5% bupivacaine by visualizing the local anesthetic spread linearly. In the rhomboid intercostal block group, the ipsilateral arm is positioned towards the chest, allowing the scapula to move laterally and the area called auscultation triangle to be opened, and after the skin disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and intercostal muscles will be defined in the auscultation triangle region, and T5-6 level with an in-plane approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain management	record of postoperative visual analog scala 0-10 values	postoperatif first 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	record of postoperative opioid consumption with patients control device	postoperatif first 24 hours.

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: MELIHA ORHON ERGUN, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): October 26, 2023
• Study Completion (Estimated): November 15, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ESPB; RHOMBOİD BLOCK; OPİOİD; POSTOPERATİVE PAIN
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 09.2022.756

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No