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Completed

NCT Number: NCT04633850

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

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

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Key information

Conditions

Postoperative Pain Local Anesthesia Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms Thoracoscopic Surgery Video Assisted Thoracoscopic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, Region of Northern Jutland, 9000, Denmark

About this study

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 (intravenous (IV) dexamethasone) will result in better pain management.

The primary plan was to evaluate the effect of adding IV dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol N-20200040 approved by the Ethics Committee of Northern Jutland on February 2nd 2021).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Intravenous dexamethasone 8 mg. Given once at the end of surgery.

Bupivacain

Drug

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 outcomes

  1. Total equipotent dose of opioids

    Time frame: 24 hours

    Sum of equipotent opioid doses during the first 24 hours after surgery

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Jannie Bisgaard Stæhr

Other

Registry information

Official study title

Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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