Efficacy of Intercostal Block Versus Pectoral Nerve Block II

Efficacy of Intercostal Block Versus Pectoral Nerve Block II in Controlling Acute Post-surgical Pain in Thoracoscopic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Thoracic Surgical Procedures
• Intervention / Treatment: Procedure: PECS II block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Recruiting
    • Carmel Medical Center
    • Contact: Dan LEVY FABER, MD; Phone Number: 97248250646; Email: DANLf@clalit.org.il
    • Contact: Firhas Darwshe, MD; Phone Number: 97248250289; Email: FirasDa@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Dan LEVY FABER, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Intercostal block; Pectoral nerve block II
• Other Study ID Numbers: CMC-18-0191-CTIL

Drug and device information, study documents

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