Postoperative PainPhase 2NCT05038007
Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades
A Phase 2 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Postoperative Pain and Lung Cancer, run by Jannie Bisgaard Stæhr at 1 site in Denmark.
Trial summary
To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery
- What is being tested?
- Liposomal bupivacaine and Bupivacaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2021to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults independent of sex with an age of ≥ 18 years
- Patients undergoing VATS as a part of either examination or treatment of lung cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital
Aalborg, Region of Northern Jutland, 9000
About this study
Official title: Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial
To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.
Read the 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.
- Conditions
- Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Blockades Neuromuscular, Anesthesia, Local
- Being tested
- Liposomal bupivacaine, Bupivacaine Hydrochloride
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
As prior described
Bupivacaine HydrochlorideDrug
Also called Marcaine
As prior described
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Bupivacaine Hydrochloride in perioperative intercostal blockades Receives: Drug: Bupivacaine Hydrochloride |
| Intervention | Experimental | Liposomal bupivacaine in perioperative intercostal blockades Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesic effect
Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
Measured: 48 hours
Secondary outcomes (5)
Total equipotent opioid dose
Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
Measured: 48 hours
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.
Measured: 48 hours
Mobilisation
Time in hours to full mobilisation defined as walking with or without aids.
Measured: 48 hours
Opioids at discharge
Need for opioids at discharge (yes or no and equipotent dosage)
Measured: 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
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: Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start15 Sep 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jannie Bisgaard Stæhr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jannie Bisgaard Stæhr, Aalborg University Hospital
- Investigators
- Jannie Bisgaard, MD, PhD, Principal investigator, Aalborg University Hospital, department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038007
- Sponsor's protocol ID
- AAUH-VATS-01
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05038007
- Acronym / sponsor ID
- AAUH-VATS-01
- Conditions
- Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Blockades Neuromuscular, Anesthesia, Local
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jannie Bisgaard StæhrUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Bupivacaine HydrochlorideBupivacaine Hydrochloride in perioperative intercostal blockades |
| Intervention | Experimental | Drug: Liposomal bupivacaineLiposomal bupivacaine in perioperative intercostal blockades |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults independent of sex with an age of ≥ 18 years
- Patients undergoing VATS as a part of either examination or treatment of lung cancer
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: ExparelAs prior described | Drug | Intervention |
| Bupivacaine HydrochlorideAlso: MarcaineAs prior described | Drug | Control |
Primary outcome
Duration of analgesic effect
Time frame: 48 hours
Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
5 secondary outcomes
Total equipotent opioid dose
Time frame: 48 hours
Numerical Rating Scale
Time frame: 48 hours
Mobilisation
Time frame: 48 hours
Opioids at discharge
Time frame: 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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannie Bisgaard, MD, PhD principal investigator
Aalborg University Hospital, department of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Postoperative Pain and Lung Cancer, run by Jannie Bisgaard Stæhr at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jannie Bisgaard, MD, PhD (97660578 ext. 0045, j.staehr@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesic effect (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.