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

Primary Purpose

Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine Hydrochloride
Sponsored by
Jannie Bisgaard Stæhr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Bupivacaine Hydrochloride in perioperative intercostal blockades

Liposomal bupivacaine in perioperative intercostal blockades

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total equipotent opioid dose
Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
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.
Mobilisation
Time in hours to full mobilisation defined as walking with or without aids.
Opioids at discharge
Need for opioids at discharge (yes or no and equipotent dosage)
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.

Full Information

First Posted
August 25, 2021
Last Updated
September 16, 2021
Sponsor
Jannie Bisgaard Stæhr
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1. Study Identification

Unique Protocol Identification Number
NCT05038007
Brief Title
Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades
Official Title
Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jannie Bisgaard Stæhr

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Blockades Neuromuscular, Anesthesia, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Bupivacaine Hydrochloride in perioperative intercostal blockades
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Liposomal bupivacaine in perioperative intercostal blockades
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
As prior described
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
Marcaine
Intervention Description
As prior described
Primary Outcome Measure Information:
Title
Duration of analgesic effect
Description
Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Total equipotent opioid dose
Description
Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
Time Frame
48 hours
Title
Numerical Rating Scale
Description
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.
Time Frame
48 hours
Title
Mobilisation
Description
Time in hours to full mobilisation defined as walking with or without aids.
Time Frame
48 hours
Title
Opioids at discharge
Description
Need for opioids at discharge (yes or no and equipotent dosage)
Time Frame
Not fixed. On average 4 days and a maximum of 3 months.
Title
Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish
Description
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.
Time Frame
Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jannie Bisgaard, MD, PhD
Phone
97660578
Ext
0045
Email
j.staehr@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip Sperling, BSc
Phone
21141411
Ext
0045
Email
phis@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jannie Bisgaard, MD, PhD
Organizational Affiliation
Aalborg University Hospital, department of Anaesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
Region Of Northern Jutland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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