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Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients

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: NCT04633850
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jannie Bisgaard Stæhr, Aalborg University Hospital

Brief Summary:
To investigate the effect of intercostal blockade with and without adjuvants.

Condition or disease Intervention/treatment
Postoperative Pain Lung Cancer Video Assisted Thoracoscopic Surgery Thoracoscopic Surgery Nerve Block Local Anesthesia Drug: Dexamethasone Drug: Bupivacaine with Adrenaline Drug: Bupivacain

Detailed Description:

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.

At Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.

The aim of this study is to investigate if intercostal nerve blockade with adjuvants (dexamethasone and adrenaline) will result in better pain management.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Group/Cohort Intervention/treatment
Before implementation
Perineural bupivacaine without adjuvants.
Drug: Bupivacain

Bupivacaine dose according to weight. <60 kg: Total dose 100mg 60-90kg: Total dose 150mg >90kg: Total dose 200mg

Given once at the end of surgery.


After implementation
Perineural bupivacaine with adjuvants (adrenaline) and intravenous dexamethasone.
Drug: Dexamethasone
Intravenous dexamethasone 8 mg. Given once at the end of surgery.

Drug: Bupivacaine with Adrenaline

Perineural injection under thoracoscopic guidance Adrenalin 5micrograms/ml, total dose 200micrograms Bupivacaine dose according to weight. <60 kg: Total dose 100mg 60-90kg: Total dose 150mg >90kg: Total dose 200mg

Given once at the end of surgery.





Primary Outcome Measures :
  1. Total equipotent dose of opioids [ Time Frame: 24 hours ]
    Sum of equipotent opioid doses during the first 24 hours after surgery


Secondary Outcome Measures :
  1. Time to first administration of opioids after surgery [ Time Frame: 48 hours ]
    In hours and minuts

  2. Numerical rating scale score [ Time Frame: 24 hours ]
    Pain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers.

  3. Time for full mobilization [ Time Frame: Through study completion, an average of 1 week ]
    The total time for full mobilization (walk with support)

  4. Total dose of non-opioid analgesics [ Time Frame: 24 hours ]
    Sum of non-opioid doses during the first 24 hours after surgery

  5. The need for pain medication at discharge [ Time Frame: At discharge from hospital, an average of 1 week ]
    The need for pain medication at discharge (all forms, type, dose)

  6. Postoperative complication (Empyema) [ Time Frame: At discharge from hospital, an average of 1 week ]
    Empyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

  7. Postoperative complication (Air leakage) [ Time Frame: At discharge from hospital, an average of 1 week ]
    Air leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

  8. Postoperative complication (Reoperation) [ Time Frame: At discharge from hospital, an average of 1 week ]
    Reoperation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

  9. Postoperative complication (Pneumonia) [ Time Frame: At discharge from hospital, an average of 1 week ]
    Pneumonia (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

  10. Postoperative complication (Drainage of pleural effusion) [ Time Frame: At discharge from hospital, an average of 1 week ]
    Pleural effusion (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

  11. Postoperative complication (Oyxgen therapy) [ Time Frame: At discharge from hospital, an average of 1 week ]
    The need for supplemental oxygen therapy and need for mechanical ventilation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.
Criteria

Inclusion Criteria:

° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer.

Exclusion Criteria:

  • Inability to understand verbal and written information.
  • Preexisting chronic pain condition.
  • Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin).
  • Previous thoracic surgery.
  • Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax.
  • Pregnant women.
  • Autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). General muscle weakness or atrophy.
  • Hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline.
  • Preoperative epidural anaesthesia.

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): NCT04633850


Contacts
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Contact: Jannie Bisgaard Stæhr, PhD, MD 97660578 ext +45 j.staehr@rn.dk
Contact: Julie Læbel Svendsen, MS 23383808 ext +45 julie.svendsen@rn.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Region Of Northern Jutland, Denmark, 9000
Contact: Jannie Bisgaard Stæhr, PhD, MD    97660578 ext +45    j.staehr@rn.dk   
Principal Investigator: Jannie Bisgaard Stæhr, PhD, MD         
Sub-Investigator: Julie Læbel Svendsen, MS         
Sub-Investigator: Allan Vestergaard Danielsen, MD         
Sponsors and Collaborators
Jannie Bisgaard Stæhr
Investigators
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Principal Investigator: Jannie Bisgaard Stæhr, PhD, MD Department of Anaesthesia
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Responsible Party: Jannie Bisgaard Stæhr, MD PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04633850    
Other Study ID Numbers: Smerter efter VATS
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents