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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05038007
• Other study ID #: AAUH-VATS-01
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Lung Cancer
• Lung Neoplasms
• Postoperative Pain
• Video Assisted Thoracoscopic Surgery

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)