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

Study Overview
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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).

Official Title
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Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study

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

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Bupivacain


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before implementation<br>Perineural bupivacaine without adjuvants. | Drug: Bupivacain<br>* 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.<br>|
| After implementation<br>Perineural bupivacaine with intravenous dexamethasone. | Drug: Dexamethasone<br>* Intravenous dexamethasone 8 mg. Given once at the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total equipotent dose of opioids | Sum of equipotent opioid doses during the first 24 hours after surgery | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first administration of opioids after surgery | In hours and minuts | 48 hours | 
| 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 | 
| Time for full mobilization | The total time for full mobilization (walk with support) | Through study completion, an average of 1 week | 
| Total dose of non-opioid analgesics | Sum of non-opioid doses during the first 24 hours after surgery | 24 hours | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |