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

Phase 2

• Conditions: Blockades Neuromuscular; Anesthesia, Local; Postoperative Pain; Lung Cancer; Video Assisted Thoracoscopic Surgery
• Interventions: Drug: Bupivacaine Hydrochloride; Drug: Liposomal bupivacaine

• Registration Number: NCT05038007
• Lead Sponsor: Jannie Bisgaard Stæhr

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.

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-31
• Status Verified: 2021-09
• Study First Posted: 2021-09-08
• Study Start: 2021-09-15
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Bupivacaine Hydrochloride	Bupivacaine Hydrochloride in perioperative intercostal blockades
Intervention	Liposomal bupivacaine	Liposomal bupivacaine in perioperative intercostal blockades

Primary Outcome Measures

Name	Time	Method
Duration of analgesic effect	48 hours	Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids

Secondary Outcome Measures

Name	Time	Method
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.
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.
Total equipotent opioid dose	48 hours	Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
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)

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Region Of Northern Jutland, Denmark