Opioid-free Anesthesia With ESPB in VATS Operation

NCT05321576 | Completed

• 1 other identifier: 09.2022.100
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with an ASA score of 3 and below, who will undergo lobectomy with video-assisted thoracic surgery (VATS) method, and who gave informed consent will be included in this study. Patients with contraindications for the application of either of the two methods, with known chronic pain, opioid use, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, those taking anticoagulants, and those with infection at the injection site will not be included in the study. In addition, patients in the ESPB group who required intraoperative opioids, patients who failed ESPB, and patients who underwent open surgery in both groups will not be included in the analysis. Patients who agree to participate in the study will be randomly assigned to one of the study's opioid-free anesthesia and ESPB (erector spina plan block) (Group 1) or standard opioid (Group 2, control) anesthesia groups. Randomization will be at the 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 at random before the procedure for each patient, and procedures will be carried out according to the group specified on the paper.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  measurement of postoperatif opioid requirement and consumption

  the first 48 hours after surgery

Study Arms (2)

erector spinae plane block group

ACTIVE COMPARATOR

Before this process, it will be produced from the bupivacaine plan, which will be made by entering unilaterally 3 cm lateral in the ultrasound to be made from a work section that will be made before the shipment and by lidocaine.

Procedure: Erector spinae plane block (ESPB) technique without opioid use

control group

ACTIVE COMPARATOR

give opiod in this group of patients

Procedure: Erector spinae plane block (ESPB) technique without opioid use

Interventions

Erector spinae plane block (ESPB) technique without opioid use PROCEDURE

Local anesthetic injection to the erector spinae muscle plane at T5 level on the operation side.

Also known as: Standard opioid anesthesia

control group; erector spinae plane block group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lobectomy with video-assisted thoracic surgery (VATS) method
• ASA score of 3 and below
• willing to be included

You may not qualify if:

• chronic pain
• current opioid use
• local anesthetic allergy
• spinal deformity or mental or psychiatric problems that prevent cooperation
• anticoagulant use
• infection at the injection site

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 11, 2022
• Study Start: March 10, 2022
• Primary Completion: April 10, 2022
• Study Completion: May 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-03

Locations

TU (1)