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Clinical Trials/NCT05618210
NCT05618210CompletedNot Applicable

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

Marmara University1 site in 1 country76 target enrollmentStarted: June 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
postoperative pain management

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

erector spinae plane block group

Active Comparator

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.

Intervention: regional anesthesia (Other)

Rhomboid block

Active Comparator

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.

Intervention: regional anesthesia (Other)

Outcomes

Primary Outcomes

postoperative pain management

Time Frame: postoperatif first 24 hours.

record of postoperative visual analog scala 0-10 values

Secondary Outcomes

  • opioid consumption(postoperatif first 24 hours.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meliha Orhon

assistant professor

Marmara University

Study Sites (1)

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