Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block

Comparison of the Results of Ultrasound-Guided Thoracic Paravertebral Block and Modified Pectoral Nerve Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery; A Prospective, Randomized Controlled Study

This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.

Study Overview

• Status: Completed
• Conditions: Video-assisted Thoracoscopic Surgery; Postoperative Analgesia; Thoracic Paravertebral Block
• Intervention / Treatment: Procedure: paravertebral block; Procedure: pectoral block

Detailed Description

52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups) Thoracic paravertebral block was administered from two consecutive levels for TPVB group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, visual analog scale values during at rest and coughing, time of the first analgesic request, and additional analgesic consumption were recorded.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bakirkoy
    • Istanbul, Bakirkoy, Turkey, 34147
      • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages of 18-65
• Patients who will undergo VATS
• ASA I-II-III patients

Exclusion Criteria:

• Patients with ASA IV
• Clinically diagnosis of spinal or chest wall deformity or pathology
• Clinically known local anesthetic allergy
• Morbid obesity (body mass index>40 kg m2)
• Clinically diagnosis of opioid, alcohol and substance dependence
• Clinically diagnosis of psychiatric disease
• Coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: paravertebral group; The investigators performed Paravertebral block to that patient group for postoperative analgesia	Procedure: paravertebral block; The investigators performed Paravertebral block to that patient group for postoperative analgesia
ACTIVE_COMPARATOR: pectoral group; The investigators performed pectoral block to that patient group for postoperative analgesia	Procedure: pectoral block; The investigators performed pectoral block to that patient group for postoperative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative 24-hours total morphine consumption of patients	This will be measured only one time by pca device at the 24th hour after surgery.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale values of patients	Visual Analog Scale (VAS, 0-10; 0= no pain and 10= very severe unbearable pain) at 0-1-2-4-8-12 and 24th hours	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Study Director: Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2017
• Primary Completion (ACTUAL): August 28, 2018
• Study Completion (ACTUAL): August 28, 2018

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (ACTUAL): April 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Thoracic paravertebral block,; pectoralis block,; Video-assisted thoracoscopic surgery,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 2017-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No