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

NCT05038007 | Unknown Phase 2 DMC

• 1 other identifier: AAUH-VATS-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Lung Cancer; Video Assisted Thoracoscopic Surgery; Blockades Neuromuscular; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Duration of analgesic effect

  Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids

  48 hours

Secondary Outcomes (5)

• Total equipotent opioid dose

  48 hours

• Numerical Rating Scale

  48 hours

• Mobilisation

  48 hours

• Opioids at discharge

  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

  Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months)

Study Arms (2)

Control

ACTIVE COMPARATOR

Bupivacaine Hydrochloride in perioperative intercostal blockades

Drug: Bupivacaine Hydrochloride

Intervention

EXPERIMENTAL

Liposomal bupivacaine in perioperative intercostal blockades

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

As prior described

Also known as: Exparel

Intervention

Bupivacaine Hydrochloride DRUG

As prior described

Also known as: Marcaine

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults independent of sex with an age of ≥ 18 years
• Patients undergoing VATS as a part of either examination or treatment of lung cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jannie Bisgaard Stæhr: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Region of Northern Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Lung Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jannie Bisgaard, MD, PhD

  Aalborg University Hospital, department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannie Bisgaard, MD, PhD

CONTACT

97660578; j.staehr@rn.dk

Phillip Sperling, BSc

CONTACT

21141411; phis@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 8, 2021
• Study Start: September 15, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 31, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)