Pleural NeoplasmsPhase 4NCT05121233
Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
A Phase 4 study testing Diclofenac in people with Pleural Neoplasms and Aspiration, Respiratory, run by Assiut University.
Trial summary
This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pleural Neoplasms, Aspiration, Respiratory, Pleural Effusion
- What is being tested?
- Diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Oct 2022
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of both genders.
- Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention
Who cannot join
- Children and patients less than 18 years old.
- Pregnant and lactating ladies.
- Patients with disturbed level of consciousness.
- Patients with known bleeding disorders.
- Patients with advanced liver and kidney disorders.
- Patients with known hypersensitivity to NSAIDS.
- Patients with chronic chest diseases.
- Patients who refuse to participate in the trial
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.
Read the detailed description
Interventional thoracic ultrasonography (TUS) includes both diagnostic and therapeutic procedures. Fine-needle aspiration biopsy , Tru-cut Pleural or lung parenchymal biopsy and Cope or Abrams needles pleural biopsies are examples of diagnostic procedures while ultrasound guided thoracentesis, pleural aspiration for pneumothorax, placement of chest tubes, and indwelling catheter insertion, or pleurodesis are common therapeutic procedures.
Thoracic ultrasound guided procedures are safe and tolerable. Pain, pneumothorax, bleeding, infection, and procedure failure are the possible complications of TUS guided procedures. Lidocaine 1% should be infiltrated prior to the procedure, paying particular attention to the skin, periosteum and the pleura as a local anesthesia.
To reduce pain, analgesia should be considered as premedication. Despite the apparent common sense of this approach, there is little established evidence of the effect from these medications.
- Conditions
- Pleural Neoplasms, Aspiration, Respiratory, Pleural Effusion, Lung Neoplasms, Pneumothorax, Pyothorax
- Being tested
- Diclofenac, Placebo
- Medical subject headings
- Pleural Neoplasms, Respiratory Aspiration, Pleural Effusion, Lung Neoplasms, Pneumothorax, Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
a single dose 75 mg IV diclofenac by infusion prior to the procedure
PlaceboDrug
single dose iv placebo (saline ) by infusion prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Active comparator | Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure Receives: Drug: Diclofenac |
| Placebo | Placebo comparator | Group B who will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by Numerical Rating Scale (NRS)
evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures by Numerical Rating Scale , patient is asked to indicate his/her perceived pain intensity , the patient grades their own pain on a scale between 1 to 10
Measured: 30 minutes
Satisfaction assessed by the Visual Analogue Scale (VAS)
satisfaction assessment by Visual Analogue Scale , series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Measured: 30 minutes
performance time of transthoracic ultrasound guided procedures
assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone
Measured: up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pleural NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Ahmed AbdAllah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121233
- Sponsor's protocol ID
- pain in TUS guided procedures
- Status last verified
- Nov 2021
- First submitted
- 25 Sep 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Almolla J, Balconi G. Interventional ultrasonography of the chest: Techniques and indications. J Ultrasound. 2011 Mar;14(1):28-36. doi: 10.1016/j.jus.2011.01.005. Epub 2011 Feb 12.
PubMed 23396954Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.
PubMed 20696688Rahman NM, Pepperell J, Rehal S, Saba T, Tang A, Ali N, West A, Hettiarachchi G, Mukherjee D, Samuel J, Bentley A, Dowson L, Miles J, Ryan CF, Yoneda KY, Chauhan A, Corcoran JP, Psallidas I, Wrightson JM, Hallifax R, Davies HE, Lee YC, Dobson M, Hedley EL, Seaton D, Russell N, Chapman M, McFadyen BM, Shaw RA, Davies RJ, Maskell NA, Nunn AJ, Miller RF. Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2641-53. doi: 10.1001/jama.2015.16840.
PubMed 26720026Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.
PubMed 4899510
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
- ClinicalTrials.gov ID
- NCT05121233
- Acronym / sponsor ID
- pain in TUS guided procedures
- Conditions
- Pleural Neoplasms, Aspiration, Respiratory, Pleural Effusion, Lung Neoplasms, Pneumothorax, Pyothorax
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 16 Nov 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.
This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.
Detailed description
Interventional thoracic ultrasonography (TUS) includes both diagnostic and therapeutic procedures. Fine-needle aspiration biopsy , Tru-cut Pleural or lung parenchymal biopsy and Cope or Abrams needles pleural biopsies are examples of diagnostic procedures while ultrasound guided thoracentesis, pleural aspiration for pneumothorax, placement of chest tubes, and indwelling catheter insertion, or pleurodesis are common therapeutic procedures.
Thoracic ultrasound guided procedures are safe and tolerable. Pain, pneumothorax, bleeding, infection, and procedure failure are the possible complications of TUS guided procedures. Lidocaine 1% should be infiltrated prior to the procedure, paying particular attention to the skin, periosteum and the pleura as a local anesthesia.
To reduce pain, analgesia should be considered as premedication. Despite the apparent common sense of this approach, there is little established evidence of the effect from these medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Active comparator | Drug: DiclofenacGroup A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure |
| Placebo | Placebo comparator | Drug: PlaceboGroup B who will receive placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients of both genders.
- Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention
Key exclusion criteria (8 listed)
- Children and patients less than 18 years old.
- Pregnant and lactating ladies.
- Patients with disturbed level of consciousness.
- Patients with known bleeding disorders.
- Patients with advanced liver and kidney disorders.
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 |
|---|---|---|
| Diclofenaca single dose 75 mg IV diclofenac by infusion prior to the procedure | Drug | Diclofenac |
| Placebosingle dose iv placebo (saline ) by infusion prior to the procedure | Drug | Placebo |
Primary outcome
Pain intensity assessed by Numerical Rating Scale (NRS)
Time frame: 30 minutes
evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures by Numerical Rating Scale , patient is asked to indicate his/her perceived pain intensity , the patient grades their own pain on a scale between 1 to 10
Satisfaction assessed by the Visual Analogue Scale (VAS)
Time frame: 30 minutes
satisfaction assessment by Visual Analogue Scale , series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
performance time of transthoracic ultrasound guided procedures
Time frame: up to 20 minutes
assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Background: PubMed 23396954Almolla J, Balconi G. Interventional ultrasonography of the chest: Techniques and indications. J Ultrasound. 2011 Mar;14(1):28-36. doi: 10.1016/j.jus.2011.01.005. Epub 2011 Feb 12.
- Background: PubMed 20696688Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.
- Background: PubMed 26720026Rahman NM, Pepperell J, Rehal S, Saba T, Tang A, Ali N, West A, Hettiarachchi G, Mukherjee D, Samuel J, Bentley A, Dowson L, Miles J, Ryan CF, Yoneda KY, Chauhan A, Corcoran JP, Psallidas I, Wrightson JM, Hallifax R, Davies HE, Lee YC, Dobson M, Hedley EL, Seaton D, Russell N, Chapman M, McFadyen BM, Shaw RA, Davies RJ, Maskell NA, Nunn AJ, Miller RF. Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2641-53. doi: 10.1001/jama.2015.16840.
- Background: PubMed 4899510Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac in people with Pleural Neoplasms and Aspiration, Respiratory, run by Assiut University.
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 8 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 mostafa mahmoud ahmed (0201001554241, doc.mostafa5454@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed by Numerical Rating Scale (NRS) (time frame: 30 minutes). 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?
On the ClinicalTrials.gov record for NCT05121233, which also lists 4 linked publications.
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 Nov 2021.