Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades

Study Overview
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Brief Summary
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To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.

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 examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.

Official Title
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Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial

Conditions
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Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Blockades Neuromuscular, Anesthesia, Local

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults independent of sex with an age of ≥ 18 years Patients undergoing VATS as a part of either examination or treatment of lung cancer Exclusion Criteria: Patients who are unable to understand oral and written information. Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery. Pregnant and nursing women. Patients with hypersensitivity / allergy / Intolerance to dexamethasone or bupivacaine. Patients receiving a planned preoperative epidural blockade during their stay. Patients converted to open surgery.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Bupivacaine Hydrochloride in perioperative intercostal blockades | Drug: Bupivacaine Hydrochloride<br>* As prior described<br>* Other names: Marcaine;|
| Experimental: Intervention<br>Liposomal bupivacaine in perioperative intercostal blockades | Drug: Liposomal bupivacaine<br>* As prior described<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesic effect | Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total equipotent opioid dose | Total equipotent opioid dose in milligrams during the first 48 hours after surgery. | 48 hours | 
| Numerical Rating Scale | Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable during the first two postoperative days. | 48 hours | 
| Mobilisation | Time in hours to full mobilisation defined as walking with or without aids. | 48 hours | 
| Opioids at discharge | Need for opioids at discharge (yes or no and equipotent dosage) | Not fixed. On average 4 days and a maximum of 3 months. | 
| Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish | Patients are asked to fill out a questionnaire rating their general satisfaction with pain management and sufficiency of pain treatment on a scale from 0 to 10. The questionnaire also assess whether the patients had any perceived side effects and how uncomfortable they were on a scale from 0 to 10. | Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months) |