Patient Controlled Erector Spinae Block at VATS

NCT04121000 | Completed DMC

• 1 other identifier: 2019-79-08/05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Erector Spinae Block,; VATS

Outcome Measures

Primary Outcomes (1)

• Perioperative and postoperative analgesic needs of patients

  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.

  Change in VAS scores at the first 48 hours

Secondary Outcomes (1)

• side effect.

  1st, 4rd, 8th,12th, 24th, 36th and 48 th hours after the procedure.

Study Arms (2)

Erector Spinae Block for VATS Group

EXPERIMENTAL

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.

Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY

Patient - Controlled Analgesia for VATS Group

EXPERIMENTAL

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

Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY

Interventions

VIDEO ASSISTED THOTACOSOPIC SURGERY PROCEDURE

VATS

Erector Spinae Block for VATS Group; Patient - Controlled Analgesia for VATS Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• OZCAN PISKIN

  Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATED PROFESSOR

Model Details: The study will be a two-arm parallel assignment. One group will receive erector spinae block and the other will receive PCA.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 9, 2019
• Study Start: June 25, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 31, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)