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Serratus Anterior Plane Block Versus Intercostal Nerve Block for Postoperative Analgesia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250272
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Saeyoung Kim, MD, PhD, Kyungpook National University Hospital

Brief Summary:
A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after video-assisted thoracoscopic lobectomy.

Condition or disease Intervention/treatment Phase
Analgesia Postoperative Pain Lung Cancer Procedure: Thoracoscopic lobectomy Not Applicable

Detailed Description:

Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.

In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.

Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in video-assisted thoracoscopic lobectomy. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in lung cancer patients who have undergone video-assisted thoracoscopic lobectomy.

This prospective study will discover the efficacy and differences between two methods.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Serratus Anterior Plane Block vs. Intercostal Nerve Block for Postoperative Analgesic Effect After Video-assisted Thoracoscopic Lobectomy: A Randomized Prospective Study
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Serratus Anterior Plane Block
Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.
Procedure: Thoracoscopic lobectomy
Thoracoscopic lobectomy was performed for lung cancer

Active Comparator: Intercostal Nerve Block
Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site.
Procedure: Thoracoscopic lobectomy
Thoracoscopic lobectomy was performed for lung cancer




Primary Outcome Measures :
  1. Postoperative pain: numeric rating scale [ Time Frame: at postanesthesia care unit (PACU) ]
    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

  2. Postoperative pain: numeric rating scale [ Time Frame: 3 hours later operation ]
    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

  3. Postoperative pain: numeric rating scale [ Time Frame: 6 hours later operation ]
    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

  4. Postoperative pain: numeric rating scale [ Time Frame: 12 hours later operation ]
    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

  5. Postoperative pain: numeric rating scale [ Time Frame: 24 hours later operation ]
    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)


Secondary Outcome Measures :
  1. Number of analgesics consumption [ Time Frame: through study completion, an average of 1 yea ]
    If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.

  2. Amount of analgesics consumption [ Time Frame: : through study completion, an average of 1 year ]
    If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lung cancer
  • American Society of Anesthesiologists (ASA) I-III class
  • Video-assisted thoracoscopic lobectomy

Exclusion Criteria:

  • previous history of allergy to local anesthetics
  • psychological disorder
  • chronic analgesics or sedatives use
  • coagulopathy
  • The presence of systemic infection or local infection at injection site
  • Pregnancy

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): NCT04250272


Contacts
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Contact: Jimin Heo +82-53-420-5430 knuhmrc@knu.ac.kr
Contact: Saeyoung Kim +82-53-420-5873 saeyoungkim7@gmail.com

Locations
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Korea, Republic of
Kyungpook national university hospital Recruiting
Daegu, Korea, Republic of, 700-412
Contact: Jimin Heo    82-53-420-5430    knuhmrc@knu.ac.kr   
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Principal Investigator: Saeyoung Kim Kyungpook National University Hospital
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Responsible Party: Saeyoung Kim, MD, PhD, Associate professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT04250272    
Other Study ID Numbers: 2019-07-008-002
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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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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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations