NCT04633850

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

November 3, 2020

Last Update Submit

June 28, 2021

Conditions

Postoperative PainLung CancerVideo Assisted Thoracoscopic SurgeryThoracoscopic SurgeryNerve BlockLocal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Total equipotent dose of opioids

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

    24 hours

Secondary Outcomes (11)

  • Time to first administration of opioids after surgery

    48 hours

  • Numerical rating scale score

    24 hours

  • Time for full mobilization

    Through study completion, an average of 1 week

  • Total dose of non-opioid analgesics

    24 hours

  • The need for pain medication at discharge

    At discharge from hospital, an average of 1 week

  • +6 more secondary outcomes

Study Arms (2)

Before implementation

Perineural bupivacaine without adjuvants.

Drug: Bupivacain

After implementation

Perineural bupivacaine with intravenous dexamethasone.

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

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

After implementation
BupivacainDRUG

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.

Before implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, Region of Northern Jutland, 9000, Denmark

Location

Related Publications (1)

  • Lobel J, Danielsen AV, Sperling PK, Bisgaard J. Intravenous dexamethasone in pain treatment after video-assisted thoracoscopic surgery. Dan Med J. 2024 Feb 12;71(3):A05230317. doi: 10.61409/A05230317.

    PMID: 38445317DERIVED

MeSH Terms

Conditions

Pain, PostoperativeLung Neoplasms

Interventions

DexamethasoneBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jannie Bisgaard Stæhr, PhD, MD

    Department of Anaesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 18, 2020

Study Start

September 8, 2020

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

DK(1)