Efficacy of Intercostal Block Versus Pectoral Nerve Block II

Overview

The investigators will evaluate the efficacy of two types of pain control blocks in patients going thoracoscopic surgery. Patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. This group represents the existent treating policy.

In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen. The investigators hope to find which pain control block is superior.

Full Title of Study: “Efficacy of Intercostal Block Versus Pectoral Nerve Block II in Controlling Acute Post-surgical Pain in Thoracoscopic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2021

Detailed Description

Thoracic operations are among the most post-operative painful surgeries. Without a doubt, the emergence of the thoracoscopic approaches has decreased pain severity. The classical methods of pain control that is used in the open thoracic procedures are not suitable in the thoracoscopic milieu. As such, pain control methods should be examined. The most accepted methods are those using different anesthetic blocks based on local anesthetic (Bupivacaine), whether in intercostal block or paravertebral one. Today the investigators use intercostal block consistently in thoracospoic procedures.

Recently, the use of the pectoral nerve block (Pecs II) has emerged for different chest wall surgeries, which has proved to be helpful. As a consequence,the investigators want to examine the efficiency of this block in the control of postoperative pain after thoracoscopic procedures.

In this prospective comparative study, patients will be randomly classified into two groups. In the control group, patients will get intercostal block at the end of the surgery and after then will be treated by the customary postoperative pain control regimen. This group represents the existent treating policy.

In the research group, patients with get PECS II block at the end of the surgery and will get a similar postoperative pain control regimen.

The follow up will include checking the pain level in the postoperative days, the extent of the pain relief medication until the discharge, and patient evaluation at the first post-discharge inspection.

The study will include 40 patients in each arm, which will be older than 18 years without gender limitations. This study will not include people with special demands.

Main inclusion criteria: patients planned for thoracoscopic procedures in the investigators department, capable of understanding, reading and signing on the consent form.

Main exclusion criteria: re-operation in the early post-operative period, re-operation at the same side, a known allergy to BUPIVACAINE.

In the case of conversion from thoracoscopic to open approach, patients will be expelled from the study.

The block will be performed solely by the surgeon or the anesthesiologist. Follow-up period will include the postoperative hospitalization period until the first post-discharge inspection.

Interventions

  • Procedure: PECS II block
    • Pectoral muscles Nerve block for postsurgical pain, PECS II, based on BUPIVACAINE: Pectoral muscles nerve block is a procedure in which local anesthetic is injected into two sites. between the major and minor pectoral muscles, in order to anesthetize the lateral and medial nerve. This injection is referred to as PECS I block. between the minor pectoral muscle and the anterior serratus muscle, in order to anesthetize the intercostal nerves.

Arms, Groups and Cohorts

  • No Intervention: intercostal block
    • patients will get intercostal block at the end of the surgery, control group
  • Experimental: PECS II block
    • patients with get PECS II block at the end of the surgery, research group

Clinical Trial Outcome Measures

Primary Measures

  • The use of pain medications after surgery
    • Time Frame: from the end of surgery until participant hospital release, assessed up to 4 weeks
    • The amount of pain medications used by each participant in the post surgical period

Participating in This Clinical Trial

Inclusion Criteria

  • Candidate for video assisted thoracoscopic surgery
  • Over 18 years of age
  • No known allergy to Bupivacaine
  • Candidate who can read, understand and sign inform consent

Exclusion Criteria

  • Candidate had previous surgery at the same side

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Carmel Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dan Levy Faber, Senior thoracic surgeon – Carmel Medical Center
  • Overall Official(s)
    • Dan LEVY FABER, MD, Principal Investigator, Carmel Medical Center
  • Overall Contact(s)
    • Dan LEVY FABER, MD, 97248250289, DANLf@clalit.org.il

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.