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Efficacy of Intercostal Block Versus Pectoral Nerve Block II

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ClinicalTrials.gov Identifier: NCT03937076
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Levy Faber, Carmel Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Thoracic Surgical Procedures Procedure: PECS II block Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

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.
Masking: Single (Participant)
Masking Description: Patients will not be informed as to which study group they assigned to. Only the caregivers will have this information.
Primary Purpose: Prevention
Official Title: Efficacy of Intercostal Block Versus Pectoral Nerve Block II in Controlling Acute Post-surgical Pain in Thoracoscopic Surgery
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022
Arms and Interventions
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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.

  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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937076


Contacts
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Contact: Dan LEVY FABER, MD 97248250289 DANLf@clalit.org.il

Locations
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Israel
Carmel Medical center Recruiting
Haifa, Israel, 34362
Contact: Dan LEVY FABER, MD    97248250646    DANLf@clalit.org.il   
Contact: Firhas Darwshe, MD    97248250289    FirasDa@clalit.org.il   
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Dan LEVY FABER, MD Carmel Medical Center
More Information
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Responsible Party: Dan Levy Faber, Senior thoracic surgeon, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT03937076    
Other Study ID Numbers: CMC-18-0191-CTIL
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Levy Faber, Carmel Medical Center:
Intercostal block
Pectoral nerve block II