Anesthesia, Local, Blockades Neuromuscular, Lung Cancer, Postoperative Pain, Video Assisted Thoracoscopic Surgery
Conditions
Brief summary
To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.
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 examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.
Interventions
DRUGLiposomal bupivacaine
As prior described
DRUGBupivacaine Hydrochloride
As prior described
Sponsors
Jannie Bisgaard Stæhr
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of analgesic effect | 48 hours | Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total equipotent opioid dose | 48 hours | Total equipotent opioid dose in milligrams during the first 48 hours after surgery. |
| Numerical Rating Scale | 48 hours | 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. |
| Mobilisation | 48 hours | Time in hours to full mobilisation defined as walking with or without aids. |
| Opioids at discharge | Not fixed. On average 4 days and a maximum of 3 months. | Need for opioids at discharge (yes or no and equipotent dosage) |
| Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish | Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months) | 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. |
Countries
Denmark
Contacts
Primary ContactJannie Bisgaard, MD, PhD
Backup ContactPhillip Sperling, BSc
Outcome results
None listed