Clinical trial NCT04633850: Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Official title: Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lung Cancer
Video Assisted Thoracoscopic Surgery
Thoracoscopic Surgery
Nerve Block
Local Anesthesia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.

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

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).

Eligibility 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.

Primary outcomes:
measure: Total equipotent dose of opioids
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first administration of opioids after surgery
timeFrame: 48 hours
measure: Numerical rating scale score
timeFrame: 24 hours
measure: Time for full mobilization
timeFrame: Through study completion, an average of 1 week
measure: Total dose of non-opioid analgesics
timeFrame: 24 hours
measure: The need for pain medication at discharge
timeFrame: At discharge from hospital, an average of 1 week
measure: Postoperative complication (Empyema)
timeFrame: At discharge from hospital, an average of 1 week
measure: Postoperative complication (Air leakage)
timeFrame: At discharge from hospital, an average of 1 week
measure: Postoperative complication (Reoperation)
timeFrame: At discharge from hospital, an average of 1 week
measure: Postoperative complication (Pneumonia)
timeFrame: At discharge from hospital, an average of 1 week
measure: Postoperative complication (Drainage of pleural effusion)
timeFrame: At discharge from hospital, an average of 1 week
measure: Postoperative complication (Oyxgen therapy)
timeFrame: At discharge from hospital, an average of 1 week
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Of Northern Jutland
Study officials:
affiliation: Department of Anaesthesia
name: Jannie Bisgaard Stæhr, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: