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Status unknownNCT03483415Updated Mar 30, 2018

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

An interventional study of Morphine Sulfate and Bupivacaine in Nerve Block and Video-Assisted Thoracic Surgery, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-30.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nerve Block
  • Video-Assisted Thoracic Surgery

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Grup L

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

    Drug: Morphine Sulfate · Drug: Bupivacaine

  • Active comparator
    Group P

    IV patient-controlled analgesia (PCA) morphine

    Drug: Morphine Sulfate

Interventions

  • DrugMorphine 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.

    Also known as: Morphine

  • DrugBupivacaine

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

05

What researchers measure

Primary outcomes

  1. morphine consumption

    morphine consumption

    Time frame: Postoperative 24 hours

Secondary outcomes

  1. Visual Analog Scale

    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)

    Time frame: Postoperative 24 hours

  2. side effect (Hypotension)

    side effect Hypotension

    Time frame: Postoperative 24 hours

  3. additional analgesic use

    additional analgesic use

    Time frame: Postoperative 24 hours

  4. side effect (Nausea and vomiting)

    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.

    Time frame: Postoperative 24 hours

  5. side effect (Ramsay Sedation Scale (RSS)

    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)

    Time frame: Postoperative 24 hours

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03483415
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Korgün Ökmen (Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Mar 30, 2018
Start date
May 1, 2018 (estimated)
Primary completion
Apr 1, 2019 (estimated)
Completion
Apr 1, 2019 (estimated)
Last update
Mar 30, 2018

Study contacts

korgün Ökmen, M.D
Contact
korgunokmen@gmail.com
+902242955000
Burcu Metin Ökmen, M.D
Contact
burcumetinokmen@gmail.com
+902242955000
Korgün Ökmen, M.D
principal investigator · UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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