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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483415
Recruitment Status : Unknown
Verified March 2018 by Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Nerve Block Video-Assisted Thoracic Surgery Drug: Morphine Sulfate Drug: Bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, single-blind
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of Analgesic Effect of Long Thoracic Nerve Blockade After VATS (Video-Assisted Thoracoscopic Surgery) Operation
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Grup L

IV patient-controlled analgesia (PCA) morphine

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

Drug: Morphine Sulfate
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.
Other Name: Morphine

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

Active Comparator: Group P
IV patient-controlled analgesia (PCA) morphine
Drug: Morphine Sulfate
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.
Other Name: Morphine




Primary Outcome Measures :
  1. morphine consumption [ Time Frame: Postoperative 24 hours ]
    morphine consumption


Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: Postoperative 24 hours ]
    Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)

  2. side effect (Hypotension) [ Time Frame: Postoperative 24 hours ]
    side effect Hypotension

  3. additional analgesic use [ Time Frame: Postoperative 24 hours ]
    additional analgesic use

  4. side effect (Nausea and vomiting) [ Time Frame: Postoperative 24 hours ]

    Nausea and vomiting scale

    1. Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.


  5. side effect (Ramsay Sedation Scale (RSS) [ Time Frame: Postoperative 24 hours ]
    Ramsay Sedation Scale (Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated, awake; 3. Sedatized, response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03483415


Contacts
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Contact: korgün Ökmen, M.D +902242955000 korgunokmen@gmail.com
Contact: Burcu Metin Ökmen, M.D +902242955000 burcumetinokmen@gmail.com

Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital
Investigators
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Principal Investigator: Korgün Ökmen, M.D University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

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Responsible Party: Korgün Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03483415    
Other Study ID Numbers: 2011-KAEK-25 2018/02-01
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics