Efficacy of Intercostal Block Versus Pectoral Nerve Block II

Thoracic Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03937076
• Other study ID #: CMC-18-0191-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 2022

Study information

• Verified date: July 2019
• Source: Carmel Medical Center
• Contact: Dan LEVY FABER, MD
• Phone: 97248250289
• Email: DANLf[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2022
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Surgical Procedures

Intervention

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.

Locations

Country	Name	City	State
Israel	Carmel Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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