Long Thoracic Nerve Blockade for Pain Treatment After Video-Assisted Thoracoscopic Surgery

NCT03483415 | Unknown

• 1 other identifier: 2011-KAEK-25 2018/02-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.Various regional methods of anesthesia are currently being used to achieve this goal. The aim of the study was to assess the effectiveness of Long thoracic nerve bloc on postoperative VATS analgesia.

Conditions

Nerve Block; Video-Assisted Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  morphine consumption

  Postoperative 24 hours

Secondary Outcomes (5)

• Visual Analog Scale

  Postoperative 24 hours

• side effect (Hypotension)

  Postoperative 24 hours

• additional analgesic use

  Postoperative 24 hours

• side effect (Nausea and vomiting)

  Postoperative 24 hours

• side effect (Ramsay Sedation Scale (RSS)

  Postoperative 24 hours

Study Arms (2)

Grup L

EXPERIMENTAL

IV patient-controlled analgesia (PCA) morphine \+ Ultrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine

Drug: Morphine Sulfate; Drug: Bupivacaine

Group P

ACTIVE COMPARATOR

IV patient-controlled analgesia (PCA) morphine

Drug: Morphine Sulfate

Interventions

Morphine Sulfate DRUG

Intravenous morphine infusion with PCA: Solution was concentration of 0.5 mg/mL. Loading dose of 1 mg, 0.5 mg of bolus dose and 20 min of locking time.

Also known as: Morphine

Group P; Grup L

Bupivacaine DRUG

Ultrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine

Grup L

Eligibility Criteria

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

You may qualify if:

• Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).

You may not qualify if:

• Previous history of opioid use preoperatively,
• Allergy to local anesthetics,
• The presence of any systemic infection,
• Uncontrolled arterial hypertension,
• Uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

MeSH Terms

Interventions

Morphine; Bupivacaine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Korgün Ökmen, M.D

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

korgün Ökmen, M.D

CONTACT

+902242955000; korgunokmen@gmail.com

Burcu Metin Ökmen, M.D

CONTACT

+902242955000; burcumetinokmen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, controlled, single-blind

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 30, 2018
• Study Start: May 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 30, 2018

Record last verified: 2018-03