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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Bupivacaine Hydrochloride in perioperative intercostal blockades |
|
| Intervention | Experimental | Liposomal bupivacaine in perioperative intercostal blockades |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | As prior described |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of analgesic effect | Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids | 48 hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jannie Bisgaard, MD, PhD | Contact | 97660578 | 0045 | j.staehr@rn.dk |
| Phillip Sperling, BSc | Contact | 21141411 | 0045 | phis@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jannie Bisgaard, MD, PhD | Aalborg University Hospital, department of Anaesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Region of Northern Jutland | 9000 | Denmark |
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| Bupivacaine Hydrochloride | Drug | As prior described |
|
|
| 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) |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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