Patient Controlled Erector Spinae Block at VATS

NCT ID: NCT04121000

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2020-12-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Erector Spinae Block for VATS Group

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.

Group Type: EXPERIMENTAL

VIDEO ASSISTED THOTACOSOPIC SURGERY

Intervention Type: PROCEDURE

VATS

Patient - Controlled Analgesia for VATS Group

40 patients who had VATS will receive IV PCA for postoperative analgesia managemnet.

Group Type: EXPERIMENTAL

VIDEO ASSISTED THOTACOSOPIC SURGERY

Intervention Type: PROCEDURE

VATS

Interventions

VIDEO ASSISTED THOTACOSOPIC SURGERY

VATS

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

OZCAN PISKIN, MD

ASSOCIATED PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

OZCAN PISKIN

Role: PRINCIPAL_INVESTIGATOR

Bulent Ecevit University

Locations

Zonguldak Bulent Ecevit University

Zonguldak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019-79-08/05

Identifier Type: -

Identifier Source: org_study_id