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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05038007
Other study ID # AAUH-VATS-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 15, 2021
Est. completion date May 31, 2022

Study information

Verified date September 2021
Source Aalborg University Hospital
Contact Jannie Bisgaard, MD, PhD
Phone 97660578
Email j.staehr@rn.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 31, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Liposomal bupivacaine
As prior described
Bupivacaine Hydrochloride
As prior described

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 Duration of analgesic effect Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids 48 hours
Secondary Total equipotent opioid dose Total equipotent opioid dose in milligrams during the first 48 hours after surgery. 48 hours
Secondary 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
Secondary Mobilisation Time in hours to full mobilisation defined as walking with or without aids. 48 hours
Secondary 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.
Secondary 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)
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