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

NCT ID: NCT05038007

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

Bupivacaine Hydrochloride in perioperative intercostal blockades

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

As prior described

Intervention

Liposomal bupivacaine in perioperative intercostal blockades

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

As prior described

Interventions

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Liposomal bupivacaine

As prior described

Intervention Type DRUG

Bupivacaine Hydrochloride

As prior described

Intervention Type DRUG

Other Intervention Names

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Exparel Marcaine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jannie Bisgaard Stæhr

OTHER

Sponsor Role lead

Responsible Party

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Jannie Bisgaard Stæhr

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jannie Bisgaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital, department of Anaesthesiology

Locations

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Aalborg University Hospital

Aalborg, Region of Northern Jutland, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Jannie Bisgaard, MD, PhD

Role: CONTACT

97660578 ext. 0045

Phillip Sperling, BSc

Role: CONTACT

21141411 ext. 0045

Other Identifiers

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AAUH-VATS-01

Identifier Type: -

Identifier Source: org_study_id

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