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

NCT ID: NCT04633850

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-04-28

Brief Summary

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

Detailed Description

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Before implementation

Perineural bupivacaine without adjuvants.

Bupivacain

Intervention Type 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.

After implementation

Perineural bupivacaine with intravenous dexamethasone.

Dexamethasone

Intervention Type DRUG

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

Interventions

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Dexamethasone

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jannie Bisgaard Stæhr

OTHER

Sponsor Role lead

Responsible Party

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Jannie Bisgaard Stæhr

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jannie Bisgaard Stæhr, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia

Locations

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Aalborg University Hospital

Aalborg, Region of Northern Jutland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38445317 (View on PubMed)

Other Identifiers

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Smerter efter VATS

Identifier Type: -

Identifier Source: org_study_id

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