Patient Controlled Erector Spinae Block at VATS

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY

• Registration Number: NCT04121000
• Lead Sponsor: Bulent Ecevit University

Brief Summary

In this study our aim is to investigate the effects of continue erector spinae block on postoperative pain in patients who underwent thoracoscopic surgery.

Detailed Description

Open thoracic surgeries are very painful procedures. After these procedures multimodal analgesia methods such as NSAIDs, opioids, PCA (patient-controlled analgesia), infiltration analgesia and thoracal epidural block are frequently used. Of these methods thoracal epidural block is the gold standart, however this technique is very invasive and has a high risk for complications. Lately Video Assisted Thoracoscopic Surgery (VATS) has become more popular because it reduces the hospital stay and is less invasive, hence the thoracic epidural block for postoperative pain has become more questionable. In this study we aimed to investigate the effects of continue Erector Spinae Block (ESB) on postoperative pain after VATS. The study will include 80 patients.

40 patients will receive ultrasound (USG) guided ESB and 40 patients will receive PCA.

All patients will recive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. Fentanyl (1-2 µg/kg), Propofol (2-3 mg/kg) and Rocuronyum (0,5-0,8 mg/kg) will be given in induction of general anesthesia. Volume -controlled ventilation will be secured to have the values O2 saturation \>98% and en-tidal carbondioxide 30-35 mm-Hg. For the mainentanance of general anesthesia the minimal alveolar concentration of sevoflurane will be 1. After the surgery every patient will receive 1 gr paracetemol and 100 mg tramadol for postoperative pain. Furthermore every patient will receive 8 mg ondansetrone for postoperative nausesa.

After sedation and standard monitorization, 20 minutes before the induction and in the prone position the Erecor Spinae Block (ESB) procedure will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identifed in the USG the needle will be guided caudally. 0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed. The patients' VAS scores will be evaluated at the 1st,3rd, 6th, 12th, and 24th hours and will be recorded.

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Ages between 20- 75
• ASA (American Society of Anesthesiologists) Score I-III
• Undergoing elective Video Assisted Thoracic Surgery

Exclusion Criteria

• ASA Score IV and higher
• Patinets with neurological deficits
• Paitents who have major vascular damage at the same side
• Mentally retarded patients
• Patients with alcohol or drug addiction
• Patients who are allergic to local anesthetics
• Pregnancy
• Paitents with coagulopathy
• Patients with skin infection at the side of the procedure
• Patients with pneumothorax at the side of the procedure
• Patient with a pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient - Controlled Analgesia for VATS Group	VIDEO ASSISTED THOTACOSOPIC SURGERY	40 patients who had VATS will receive IV PCA for postoperative analgesia managemnet.
Erector Spinae Block for VATS Group	VIDEO ASSISTED THOTACOSOPIC SURGERY	40 patients who had VATS will receive erector spinae block for postoperative pain management. All patients will receive IV Midazolam (0.05mg/kg) premediacation. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. After sedation and standard monitorization, 20 minutes before the induction and in the prone positon the ESB procedure will be done. 10 % povidon- iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identified in the USG the needle will be guided caudally.0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed.

Primary Outcome Measures

Name	Time	Method
Perioperative and postoperative analgesic needs of patients	Change in VAS scores at the first 48 hours	Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured.

Secondary Outcome Measures

Name	Time	Method
side effect.	1st, 4rd, 8th,12th, 24th, 36th and 48 th hours after the procedure.	side effects of opioids

Trial Locations

Locations (1)

Zonguldak Bulent Ecevit University; 🇹🇷 Zonguldak, Turkey