Postoperative PainNCT04633850
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
An observational study of Postoperative Pain and Lung Cancer, run by Jannie Bisgaard Stæhr at 1 site in Denmark.
Trial summary
To investigate the effect of intercostal blockade with and without adjuvants. 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?
- Dexamethasone and Bupivacain
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Sep 2020to 28 Apr 2021
- Phase
- Observational
- 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
Study population: Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.
Who may be able to join
- ° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer.
Who cannot join
- Inability to understand verbal and written information.
- Preexisting chronic pain condition.
- Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin).
- Previous thoracic surgery.
- Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax.
- Pregnant women.
Show all 9Show fewer
- Autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). General muscle weakness or atrophy.
- Hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline.
- Preoperative epidural anaesthesia.
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: Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study
To investigate the effect of intercostal blockade with and without adjuvants.
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 investigate if intercostal nerve blockade with adjuvants (intravenous (IV) dexamethasone) will result in better pain management.
The primary plan was to evaluate the effect of adding IV dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol N-20200040 approved by the Ethics Committee of Northern Jutland on February 2nd 2021).
- Conditions
- Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Thoracoscopic Surgery, Nerve Block, Local Anesthesia
- Being tested
- Dexamethasone, Bupivacain
- 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.
DexamethasoneDrug
Intravenous dexamethasone 8 mg. Given once at the end of surgery.
BupivacainDrug
Bupivacaine dose according to weight. <60 kg: Total dose 100mg 60-90kg: Total dose 150mg >90kg: Total dose 200mg
Given once at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Before implementation | Perineural bupivacaine without adjuvants. Receives: Drug: Bupivacain | |
| After implementation | Perineural bupivacaine with intravenous dexamethasone. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total equipotent dose of opioids
Sum of equipotent opioid doses during the first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (11)
Time to first administration of opioids after surgery
In hours and minuts
Measured: 48 hours
Numerical rating scale score
Pain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers.
Measured: 24 hours
Time for full mobilization
The total time for full mobilization (walk with support)
Measured: Through study completion, an average of 1 week
Total dose of non-opioid analgesics
Sum of non-opioid doses during the first 24 hours after surgery
Measured: 24 hours
The need for pain medication at discharge
The need for pain medication at discharge (all forms, type, dose)
Measured: At discharge from hospital, an average of 1 week
Postoperative complication (Empyema)
Empyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Measured: At discharge from hospital, an average of 1 week
Postoperative complication (Air leakage)
Air leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Measured: At discharge from hospital, an average of 1 week
Postoperative complication (Reoperation)
Reoperation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Measured: At discharge from hospital, an average of 1 week
Postoperative complication (Pneumonia)
Pneumonia (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Measured: At discharge from hospital, an average of 1 week
Postoperative complication (Drainage of pleural effusion)
Pleural effusion (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Measured: At discharge from hospital, an average of 1 week
Postoperative complication (Oyxgen therapy)
The need for supplemental oxygen therapy and need for mechanical ventilation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Measured: At discharge from hospital, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start8 Sep 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
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 Stæhr, PhD, MD, Principal investigator, Department of Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633850
- Sponsor's protocol ID
- Smerter efter VATS
- Status last verified
- Jun 2021
- First submitted
- 3 Nov 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lobel J, Danielsen AV, Sperling PK, Bisgaard J. Intravenous dexamethasone in pain treatment after video-assisted thoracoscopic surgery. Dan Med J. 2024 Feb 12;71(3):A05230317. doi: 10.61409/A05230317.
PubMed 38445317
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study
- ClinicalTrials.gov ID
- NCT04633850
- Acronym / sponsor ID
- Smerter efter VATS
- Conditions
- Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Thoracoscopic Surgery, Nerve Block, Local Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jannie Bisgaard StæhrUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 18 Nov 2020 (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 intercostal blockade with and without adjuvants.
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 investigate if intercostal nerve blockade with adjuvants (intravenous (IV) dexamethasone) will result in better pain management.
The primary plan was to evaluate the effect of adding IV dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol N-20200040 approved by the Ethics Committee of Northern Jutland on February 2nd 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before implementation | – | Drug: BupivacainPerineural bupivacaine without adjuvants. |
| After implementation | – | Drug: DexamethasonePerineural bupivacaine with intravenous dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.
Key inclusion criteria (1 listed)
- ° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer.
Key exclusion criteria (9 listed)
- Inability to understand verbal and written information.
- Preexisting chronic pain condition.
- Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin).
- Previous thoracic surgery.
- Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax.
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 |
|---|---|---|
| DexamethasoneIntravenous dexamethasone 8 mg. Given once at the end of surgery. | Drug | After implementation |
| BupivacainBupivacaine dose according to weight. <60 kg: Total dose 100mg 60-90kg: Total dose 150mg >90kg: Total dose 200mg Given once at the end of surgery. | Drug | Before implementation |
Primary outcome
Total equipotent dose of opioids
Time frame: 24 hours
Sum of equipotent opioid doses during the first 24 hours after surgery
11 secondary outcomes
Time to first administration of opioids after surgery
Time frame: 48 hours
Numerical rating scale score
Time frame: 24 hours
Time for full mobilization
Time frame: Through study completion, an average of 1 week
Total dose of non-opioid analgesics
Time frame: 24 hours
The need for pain medication at discharge
Time frame: At discharge from hospital, an average of 1 week
Postoperative complication (Empyema)
Time frame: At discharge from hospital, an average of 1 week
Postoperative complication (Air leakage)
Time frame: At discharge from hospital, an average of 1 week
Postoperative complication (Reoperation)
Time frame: At discharge from hospital, an average of 1 week
Postoperative complication (Pneumonia)
Time frame: At discharge from hospital, an average of 1 week
Postoperative complication (Drainage of pleural effusion)
Time frame: At discharge from hospital, an average of 1 week
Postoperative complication (Oyxgen therapy)
Time frame: At discharge from hospital, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 38445317Lobel J, Danielsen AV, Sperling PK, Bisgaard J. Intravenous dexamethasone in pain treatment after video-assisted thoracoscopic surgery. Dan Med J. 2024 Feb 12;71(3):A05230317. doi: 10.61409/A05230317.
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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 Stæhr, PhD, MD principal investigator
Department of Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total equipotent dose of opioids (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633850, which also lists 1 linked publication.
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 1 Jul 2021.