PainPhase 3NCT02936427
Effects and Dose Response of Dexamethasone on Intercostal Blocks With Bupivicaine in Post Thoracic Surgery Patients
A Phase 3 study testing Dexamethasone in people with Pain, run by University College Dublin at 1 site in Ireland.
Trial summary
Post-op analgesia is the most important part of early and safe patient recovery in thoracic surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly improved with optimal pain control and complications and length of stay are minimized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2016to Mar 2018
- Phase
- Phase 3
- 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
- Age >18
- Consenting
- undergoing VATS procedure
Who cannot join
- Age <18
- Refusal to consent
- Equipment failure
- Allergic reactions to local anaesthetic agent
- Incipient agents or opioid
- Patients on pre-existing long-term opioid use
- Any other concomitant or surgery within 2 weeks of the thoracic surgery
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's University Hospital
Dublin, Leinster, Dublin 4
Mark C Murphy, MB, Bch Bao, 00353877680018, markmurphy1608@gmail.com
David Healy, PHD, FRCS, 00353876479219, d.healy@svuh.ie
About this study
Official title: The Effects and Dose Response of Dexamethasone on Intercostal Nerve Blocks With Bupivicaine in Post Thoracic Surgery Patients
Post-op analgesia is the most important part of early and safe patient recovery in thoracic surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly improved with optimal pain control and complications and length of stay are minimized. Most post-op thoracic complications are from decreased respiratory effort, failure to clear secretions and pulmonary infections from retained sputum with subsequent sequelae. Good post-operative analgesia not only prevents these complications but also considerably enhances early mobilization and thus, decreased hospital stay and efficient resource allocation. Early post-operative pain is also associated with late and chronic post thoracotomy pain syndromes which can be debilitating.
Pain following thoracic surgery is different to the standard surgical incision pain and is due to intercostal nerve damage, compression or traction injury to the nerve. This occurs with the incision, rib retraction, and is compounded by the on-going need for respiratory effort. The approach to managing this pain is multi-modal analgesia. The standard regimen stretches from preemptive analgesia and preoperative placement of thoracic epidurals to post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as anti-convulsants like pregabalin. However, opioid use has well-known side effects including central nervous system (CNS) and respiratory depression which unfortunately delay mobility and recovery. This has motivated opioid-sparing strategies.
The investigators study aims to assess whether the addition of perineural dexamethasone (a steroid) to the current practice of local anaesthetic wound catheters increases the efficacy and duration of analgesia provided.
Read the detailed description
Recent years have seen the importance of early mobility and respiratory toilet to minimise complications and hospital stay. Newer methods of pain relief with fewer systemic effects have become even more important. Continuous wound infiltration catheters (CWI's) aim to deliver local anaesthetic agents directly into the wound (4). This technique goes back to 1994, and has been established in this hospital and is used in a non-structured manner in thoracic surgery. Recent studies have demonstrated that the addition of dexamethasone (a steroid) to local anaesthetic agents in similar nerve blocks significantly improves the analgesic affect and prolongs the duration of the analgesia. To the best of the investigators knowledge this has not been tested in a thoracic surgery cohort of patients, though it has been tested safely and effectively in the thorax in healthy volunteers and in postoperative analgesia in abdominal and musculoskeletal post op patients. The investigators aim is to assess whether the addition of perineural dexamethasone to the local anaesthetic in CWI's is superior to the local anaesthetic alone in thoracic post operative patients, and at which dose. They also want to assess the levels of pain experienced 1 month post op to evaluate the potential effect of dexamethasone on post thoracoscopy pain syndrome.
The investigators aim is to compare the use of local anaesthetic agent in combination with perineural dexamethasone with the current practice of local anaesthetic alone at relieving pain in the immediate post op pain period. The investigators also want to assess whether the 8mg dose of dexamethasone used in similar studies is the optimal dose or whether a similar effect can be observed at a smaller dose of 4mg.
- Conditions
- Pain
- Being tested
- Dexamethasone
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone phosphate
perineural infiltration of dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group will receive normal post operative care including intercostal wound catheters however will not receive dexamethasone |
| Dexamethasone 4mg | Experimental | Participants will receive 4mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters. Receives: Drug: Dexamethasone |
| Dexamethasone 8mg | Experimental | Participants will receive 8mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of analgesia used in 24hrs
Cumulative analgesia used over 24hrs
Measured: 0- 24hrs from surgery
Amount of analgesia used in 48hrs
Cumulative analgesia used in 48 hrs
Measured: 0-48hrs from surgery
Amount of analgesia used in 1 month from date of surgery
Cumulative analgesia used over 1 month
Measured: 0hrs - 1 month from surgery
Secondary outcomes (3)
Pain reported by patient at 24hrs
Pain according to Visual analog score reported by the patient
Measured: recording of patients level of pain 24hrs post op
Pain reported by patient at 48hrs
Pain according to Visual analog score reported by the patient
Measured: recording of patients level of pain 48hrs post op
Pain reported by patient 1 month post op
Pain according to Visual analog score reported by the patient
Measured: recording of patients level of pain 1 month post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Murphy, University College Dublin
- Investigators
- Mark C Murphy, MB BcH BAO, Principal investigator, Surgical SHO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936427
- Sponsor's protocol ID
- PIL/Consentvs1
- Status last verified
- May 2017
- First submitted
- 21 May 2016
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Dose Response of Dexamethasone on Intercostal Nerve Blocks With Bupivicaine in Post Thoracic Surgery Patients
- ClinicalTrials.gov ID
- NCT02936427
- Acronym / sponsor ID
- PIL/Consentvs1
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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.
Post-op analgesia is the most important part of early and safe patient recovery in thoracic surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly improved with optimal pain control and complications and length of stay are minimized. Most post-op thoracic complications are from decreased respiratory effort, failure to clear secretions and pulmonary infections from retained sputum with subsequent sequelae. Good post-operative analgesia not only prevents these complications but also considerably enhances early mobilization and thus, decreased hospital stay and efficient resource allocation. Early post-operative pain is also associated with late and chronic post thoracotomy pain syndromes which can be debilitating.
Pain following thoracic surgery is different to the standard surgical incision pain and is due to intercostal nerve damage, compression or traction injury to the nerve. This occurs with the incision, rib retraction, and is compounded by the on-going need for respiratory effort. The approach to managing this pain is multi-modal analgesia. The standard regimen stretches from preemptive analgesia and preoperative placement of thoracic epidurals to post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as anti-convulsants like pregabalin. However, opioid use has well-known side effects including central nervous system (CNS) and respiratory depression which unfortunately delay mobility and recovery. This has motivated opioid-sparing strategies.
The investigators study aims to assess whether the addition of perineural dexamethasone (a steroid) to the current practice of local anaesthetic wound catheters increases the efficacy and duration of analgesia provided.
Detailed description
Recent years have seen the importance of early mobility and respiratory toilet to minimise complications and hospital stay. Newer methods of pain relief with fewer systemic effects have become even more important. Continuous wound infiltration catheters (CWI's) aim to deliver local anaesthetic agents directly into the wound (4). This technique goes back to 1994, and has been established in this hospital and is used in a non-structured manner in thoracic surgery. Recent studies have demonstrated that the addition of dexamethasone (a steroid) to local anaesthetic agents in similar nerve blocks significantly improves the analgesic affect and prolongs the duration of the analgesia. To the best of the investigators knowledge this has not been tested in a thoracic surgery cohort of patients, though it has been tested safely and effectively in the thorax in healthy volunteers and in postoperative analgesia in abdominal and musculoskeletal post op patients. The investigators aim is to assess whether the addition of perineural dexamethasone to the local anaesthetic in CWI's is superior to the local anaesthetic alone in thoracic post operative patients, and at which dose. They also want to assess the levels of pain experienced 1 month post op to evaluate the potential effect of dexamethasone on post thoracoscopy pain syndrome.
The investigators aim is to compare the use of local anaesthetic agent in combination with perineural dexamethasone with the current practice of local anaesthetic alone at relieving pain in the immediate post op pain period. The investigators also want to assess whether the 8mg dose of dexamethasone used in similar studies is the optimal dose or whether a similar effect can be observed at a smaller dose of 4mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group will receive normal post operative care including intercostal wound catheters however will not receive dexamethasone |
| Dexamethasone 4mg | Experimental | Drug: DexamethasoneParticipants will receive 4mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters. |
| Dexamethasone 8mg | Experimental | Drug: DexamethasoneParticipants will receive 8mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18
- Consenting
- undergoing VATS procedure
Key exclusion criteria (7 listed)
- Age <18
- Refusal to consent
- Equipment failure
- Allergic reactions to local anaesthetic agent
- Incipient agents or opioid
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 |
|---|---|---|
| DexamethasoneAlso: Dexamethasone phosphateperineural infiltration of dexamethasone | Drug | Dexamethasone 4mg, Dexamethasone 8mg |
Primary outcome
Amount of analgesia used in 24hrs
Time frame: 0- 24hrs from surgery
Cumulative analgesia used over 24hrs
Amount of analgesia used in 48hrs
Time frame: 0-48hrs from surgery
Cumulative analgesia used in 48 hrs
Amount of analgesia used in 1 month from date of surgery
Time frame: 0hrs - 1 month from surgery
Cumulative analgesia used over 1 month
3 secondary outcomes
Pain reported by patient at 24hrs
Time frame: recording of patients level of pain 24hrs post op
Pain reported by patient at 48hrs
Time frame: recording of patients level of pain 48hrs post op
Pain reported by patient 1 month post op
Time frame: recording of patients level of pain 1 month post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mark C Murphy, MB BcH BAO principal investigator
Surgical SHO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Pain, run by University College Dublin at 1 site in Ireland.
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 3 inclusion and 7 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 16 May 2017. 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 Ireland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mark C Murphy, Mb Bch BAO (00353877680018, markmurphy1608@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of analgesia used in 24hrs (time frame: 0- 24hrs from surgery). The study lists 3 primary outcomes in all. 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 16 May 2017.