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Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in 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: NCT02469610
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Levy Faber, Carmel Medical Center

Brief Summary:
It is well known that chest surgery patients suffer from high level pain in the perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain control technique for thoracoscopic approaches is still under debate. One of the most popular methods for pain control is these procedures is the Intercostal block. The Intercostal block is usually based upon topical analgesic. In this study the investigators will try to examine the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The study is a prospective comparative study. The cohort will be divided into two groups. In the control group patients will have Intercostal block after surgery and in the study group the intercostal block will be given in the beginning of the surgical procedure. All other analgesic treatment during and post-surgery will be the same in both groups. The study will evaluate pain level in the days after the surgery, analgesic medication consumption and relevant morbidity.

Condition or disease Intervention/treatment Phase
Chest Pain Surgery Other: Intercostal block Bupivacaine based Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
Study Start Date : June 2015
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : June 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Other: Intercostal block Bupivacaine based
Intercostal Bupivacaine block of 100ml over five intercostal spaces.

control
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Other: Intercostal block Bupivacaine based
Intercostal Bupivacaine block of 100ml over five intercostal spaces.




Primary Outcome Measures :
  1. Analgesic Use [ Time Frame: post operative ]
    The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)


Secondary Outcome Measures :
  1. Visual Analog Pain Scale [ Time Frame: post operative ]
    subjective patient's pain evaluation according to Visual Analog pain Scale (VAS). Visual Analog pain Scale a 1-10 score of pain. 1 being a lowest level of pain and 10 the worst pain felt by the patient.



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

Inclusion Criteria:

  • Thoracoscopic surgery candidate.
  • Over 18 years old.
  • No known allergy to Bupivacaine.
  • Patient is able to read understand and singe an inform consent.

Exclusion Criteria:

  • Previous thoracic operation in the same side.

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): NCT02469610


Locations
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Israel
CarmelMC
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
  Study Documents (Full-Text)

Documents provided by Dan Levy Faber, Carmel Medical Center:
Study Protocol  [PDF] June 28, 2016
Statistical Analysis Plan  [PDF] October 1, 2016
Informed Consent Form  [PDF] May 1, 2014

Publications:
1. Regional analgesia for video-assisted thoracic surgery: a systematic review.Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Eur J Cardiothorac Surg. 2013 Nov 27. 2. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. Taylor R, Massey S, Stuart-Smith K. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. 3. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain.Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M.Ann Thorac Surg. 2000 Dec;70(6):1872-5. 4. Preventing post-thoracotomy pain syndrome.Khelemsky Y, Noto CJ. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286. Review. 5. Prevention of chronic pain after surgical nerve injury: amputation and thoracotomy.Buchheit T, Pyati S.Surg Clin North Am. 2012 Apr;92(2):393-407. Review. 6. Paravertebral blocks.Chelly JE. Anesthesiol Clin. 2012 Mar;30(1):75-90. Review. 7. Persistent postoperative pain: where are we now? Niraj G, Rowbotham DJ. Br J Anaesth. 2011 Jul;107(1):25-9. Review.

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Responsible Party: Dan Levy Faber, Dr, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02469610    
Other Study ID Numbers: CMC-14-0123-CTIL
First Posted: June 11, 2015    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: general discricptive data only
Keywords provided by Dan Levy Faber, Carmel Medical Center:
Post surgical pain
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents