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CompletedNCT04633850Updated Jul 1, 2021

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

An observational study in Postoperative Pain, Lung Cancer and Video Assisted Thoracoscopic Surgery, sponsored by Jannie Bisgaard Stæhr. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-01.

Sponsored by Jannie Bisgaard Stæhr · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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 (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).

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Conditions studied

  • Postoperative Pain
  • Lung Cancer
  • Video Assisted Thoracoscopic Surgery
  • Thoracoscopic Surgery
  • Nerve Block
  • Local Anesthesia

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 45 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Jannie Bisgaard Stæhr is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • Before implementation

    Perineural bupivacaine without adjuvants.

    Drug: Bupivacain

  • After implementation

    Perineural bupivacaine with intravenous dexamethasone.

    Drug: Dexamethasone

Interventions

  • DrugDexamethasone

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

  • DrugBupivacain

    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.

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What researchers measure

Primary outcomes

  1. Total equipotent dose of opioids

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

    Time frame: 24 hours

Secondary outcomes

  1. Time to first administration of opioids after surgery

    In hours and minuts

    Time frame: 48 hours

  2. Numerical rating scale score

    Pain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers.

    Time frame: 24 hours

  3. Time for full mobilization

    The total time for full mobilization (walk with support)

    Time frame: Through study completion, an average of 1 week

  4. Total dose of non-opioid analgesics

    Sum of non-opioid doses during the first 24 hours after surgery

    Time frame: 24 hours

  5. The need for pain medication at discharge

    The need for pain medication at discharge (all forms, type, dose)

    Time frame: At discharge from hospital, an average of 1 week

  6. Postoperative complication (Empyema)

    Empyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

    Time frame: At discharge from hospital, an average of 1 week

  7. Postoperative complication (Air leakage)

    Air leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

    Time frame: At discharge from hospital, an average of 1 week

  8. Postoperative complication (Reoperation)

    Reoperation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

    Time frame: At discharge from hospital, an average of 1 week

  9. Postoperative complication (Pneumonia)

    Pneumonia (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

    Time frame: At discharge from hospital, an average of 1 week

  10. Postoperative complication (Drainage of pleural effusion)

    Pleural effusion (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

    Time frame: At discharge from hospital, an average of 1 week

  11. Postoperative complication (Oyxgen therapy)

    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)

    Time frame: At discharge from hospital, an average of 1 week

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Study locations

1 site
  • Aalborg University Hospital
    Aalborg, Region Of Northern Jutland 9000, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04633850
Lead sponsor
Jannie Bisgaard Stæhr
Responsible party
Jannie Bisgaard Stæhr (MD PhD, Aalborg University Hospital) — Sponsor-investigator
First posted
Nov 18, 2020
Start date
Sep 8, 2020
Primary completion
Apr 28, 2021
Completion
Apr 28, 2021
Last update
Jul 1, 2021

Study contacts

Jannie Bisgaard Stæhr, PhD, MD
principal investigator · Department of Anaesthesia

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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