PainNCT03218098
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
A study testing Lobectomy via UVATS in people with Pain, run by University of Roma La Sapienza.
Trial summary
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery? Postoperative pain control remains one of the most common problems after major lung resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Lobectomy via UVATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2016
- Phase
- Interventional
- 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
- be aged ≥ 18 years (of either gender)
- have provided written informed consent prior to participation in the study
- undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS).
Who cannot join
- rethoracotomy
- presence of pleural adhesions
- Neuropathy
- be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue [lung or parts of lymph nodes] for biological research may occur in the same patients)
About this study
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Postoperative pain control remains one of the most common problems after major lung resection. Pain is considered a major independent factor responsible for increased perioperative morbidity and mortality: in particular, in patients with preoperative compromised clinical conditions. In fact, acute pain may compromise the patient's mobilization and the secretion's clearance with secondary possible bronchial obstruction and parenchymal lung infection.
Read more
Today, the treatment of postoperative pain after lung resection is based on association of the pharmacological therapy, including systemic use of opioids and non-steroid drugs, epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve protection with the use of muscle sparing. In the literature, reduced tissue damage consequent to the use of limited surgical approaches is reported to be significantly effective in decreasing early postoperative pain. Thus, the use of a minimally invasive surgery for lung resections has proved to produce more tolerable pain and allow quicker functional recovery and lower postoperative complications. The aim of this prospective randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of postoperative pain results. Primarily, to evaluate the differences of operative time between the groups.
Secondly, to investigate the differences of pain scores between the two groups and the impact of pain reduction on functional results.
- Conditions
- Pain
- Being tested
- Lobectomy via UVATS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lobectomy via UVATSProcedure or surgery
lobectomy with small skin access 4 cm
| Study group | Role | What they receive |
|---|---|---|
| Smaller Incision | Experimental | UVATS access for lobectomy with small skin access 4 cm Receives: Procedure: Lobectomy via UVATS |
| Traditional Incision | Active comparator | UVATS access for lobectomy with longer skin access 8 cm Receives: Procedure: Lobectomy via UVATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time reduction
Operative time reduction in minutes
Measured: up to 180 min
Secondary outcomes (1)
pain score
VAS score
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startJan 2014
- Primary completionJan 2016
- Study completionJun 2016
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.
- More trials run by University of Roma La SapienzaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Ibrahim, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218098
- Sponsor's protocol ID
- 1037/2012
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
- ClinicalTrials.gov ID
- NCT03218098
- Acronym / sponsor ID
- 1037/2012
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jul 2017 (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.
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Postoperative pain control remains one of the most common problems after major lung resection. Pain is considered a major independent factor responsible for increased perioperative morbidity and mortality: in particular, in patients with preoperative compromised clinical conditions. In fact, acute pain may compromise the patient's mobilization and the secretion's clearance with secondary possible bronchial obstruction and parenchymal lung infection.
Today, the treatment of postoperative pain after lung resection is based on association of the pharmacological therapy, including systemic use of opioids and non-steroid drugs, epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve protection with the use of muscle sparing. In the literature, reduced tissue damage consequent to the use of limited surgical approaches is reported to be significantly effective in decreasing early postoperative pain. Thus, the use of a minimally invasive surgery for lung resections has proved to produce more tolerable pain and allow quicker functional recovery and lower postoperative complications. The aim of this prospective randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of postoperative pain results. Primarily, to evaluate the differences of operative time between the groups.
Secondly, to investigate the differences of pain scores between the two groups and the impact of pain reduction on functional results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smaller Incision | Experimental | Procedure: Lobectomy via UVATSUVATS access for lobectomy with small skin access 4 cm |
| Traditional Incision | Active comparator | Procedure: Lobectomy via UVATSUVATS access for lobectomy with longer skin access 8 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be aged ≥ 18 years (of either gender)
- have provided written informed consent prior to participation in the study
- undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS).
Key exclusion criteria (4 listed)
- rethoracotomy
- presence of pleural adhesions
- Neuropathy
- be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue [lung or parts of lymph nodes] for biological research may occur in the same patients)
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 |
|---|---|---|
| Lobectomy via UVATSlobectomy with small skin access 4 cm | Procedure or surgery | Smaller Incision, Traditional Incision |
Primary outcome
Operative time reduction
Time frame: up to 180 min
Operative time reduction in minutes
1 secondary outcome
pain score
Time frame: up to 48 hours
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 14 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lobectomy via UVATS in people with Pain, run by University of Roma La Sapienza.
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 4 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 14 Jul 2017. 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. 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?
Operative time reduction (time frame: up to 180 min). 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 14 Jul 2017.