Efficacy of Intercostal Block Versus Pectoral Nerve Block II

NCT ID: NCT03937076

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-05-31

Brief Summary

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.

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.

Conditions

Thoracic Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intercostal block

patients will get intercostal block at the end of the surgery, control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

PECS II block

patients with get PECS II block at the end of the surgery, research group

Group Type: EXPERIMENTAL

PECS II block

Intervention Type: PROCEDURE

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.

1. 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.

2. between the minor pectoral muscle and the anterior serratus muscle, in order to anesthetize the intercostal nerves.

Interventions

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.

1. 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.

2. between the minor pectoral muscle and the anterior serratus muscle, in order to anesthetize the intercostal nerves.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dan Levy Faber

Senior thoracic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dan LEVY FABER, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Dan LEVY FABER, MD

Role: CONTACT

DANLf@clalit.org.il

97248250289

Facility Contacts

Dan LEVY FABER, MD

Role: primary

DANLf@clalit.org.il

97248250646

Firhas Darwshe, MD

Role: backup

FirasDa@clalit.org.il

97248250289

Other Identifiers

CMC-18-0191-CTIL

Identifier Type: -

Identifier Source: org_study_id