Patient Controlled Erector Spinae Block at VATS

Sponsor

Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT04121000

Collaborator

(none)

Enrollment

Location

Arms

18.2

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY	N/A

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

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effects of Patient Controlled Erector Spinae Block on Postoperative Pain in Video Assisted Thoracoscopic Surgery (VATS) : A Randomized Controlled Study

Actual Study Start Date :

Jun 25, 2019

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY VATS
Experimental: Patient - Controlled Analgesia for VATS Group 40 patients who had VATS will receive IV PCA for postoperative analgesia managemnet.	Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY VATS

Arm

Intervention/Treatment

Experimental: 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.

Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY

VATS

Experimental: Patient - Controlled Analgesia for VATS Group

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

Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY

VATS

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zonguldak Bulent Ecevit University	Zonguldak		Turkey

Sponsors and Collaborators

Bulent Ecevit University

Investigators

Principal Investigator: OZCAN PISKIN, Bulent Ecevit University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

OZCAN PISKIN, MD, ASSOCIATED PROFESSOR, Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT04121000

Other Study ID Numbers:

2019-79-08/05

First Posted:

Oct 9, 2019

Last Update Posted:

Jun 2, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by OZCAN PISKIN, MD, ASSOCIATED PROFESSOR, Bulent Ecevit University

Erector Spinae Block,

VATS

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jun 2, 2021