Efficacy of Intercostal Block Versus Pectoral Nerve Block II

NCT03937076 | Unknown

• 1 other identifier: CMC-18-0191-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgical Procedures

Keywords

Intercostal block; Pectoral nerve block II

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intercostal block

NO INTERVENTION

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

PECS II block

EXPERIMENTAL

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

Procedure: PECS II block

Interventions

PECS II block 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.

PECS II block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Candidate had previous surgery at the same side

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical center

Haifa, 34362, Israel

RECRUITING

Study Officials

• Dan LEVY FABER, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan LEVY FABER, MD

CONTACT

97248250289; DANLf@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed as to which study group they assigned to. Only the caregivers will have this information.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior thoracic surgeon

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: June 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

IL (1)