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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04633850
Other study ID # Smerter efter VATS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 8, 2020
Est. completion date April 28, 2021

Study information

Verified date June 2021
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date April 28, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg Region Of Northern Jutland

Sponsors (1)

Lead Sponsor Collaborator
Jannie Bisgaard Stæhr

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total equipotent dose of opioids Sum of equipotent opioid doses during the first 24 hours after surgery 24 hours
Secondary Time to first administration of opioids after surgery In hours and minuts 48 hours
Secondary Numerical rating scale score Pain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers. 24 hours
Secondary Time for full mobilization The total time for full mobilization (walk with support) Through study completion, an average of 1 week
Secondary Total dose of non-opioid analgesics Sum of non-opioid doses during the first 24 hours after surgery 24 hours
Secondary The need for pain medication at discharge The need for pain medication at discharge (all forms, type, dose) At discharge from hospital, an average of 1 week
Secondary Postoperative complication (Empyema) Empyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis) At discharge from hospital, an average of 1 week
Secondary Postoperative complication (Air leakage) Air leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis) At discharge from hospital, an average of 1 week
Secondary Postoperative complication (Reoperation) Reoperation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis) At discharge from hospital, an average of 1 week
Secondary Postoperative complication (Pneumonia) Pneumonia (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis) At discharge from hospital, an average of 1 week
Secondary Postoperative complication (Drainage of pleural effusion) Pleural effusion (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis) At discharge from hospital, an average of 1 week
Secondary 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) At discharge from hospital, an average of 1 week
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