Acute PainNCT02460640
The Effects of TAP Block on Postsurgical Pain After Minimally Invasive Partial Nephrectomy:
A study testing Tap block, Morphine and Ropivacaine in people with Acute Pain and Chronic Pain, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Chronic Pain
- What is being tested?
- Tap block, Morphine and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Aug 2017
- 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
- asa score I,II,II
- patients scheduled for robot assisted partial nephrectomy
Who cannot join
- previous abdominal surgery
- inability to provide informed consent
- allergy to the anesthetic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Ultrasound-guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy. A Prospective, Randomized, Clinical Trial
Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.
- Conditions
- Acute Pain, Chronic Pain
- Being tested
- Tap block, intravenous Patient controlled analgesia, Morphine, Ropivacaine
- Keywords
- Minimally invasive surgery, Partial nephrectomy
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tap blockProcedure or surgery
intravenous patient-controlled analgesia with morphine and tap block with subcostal and posterior approach with ropivacaine 0,5% 15ml+15ml
intravenous Patient controlled analgesiaProcedure or surgery
intravenous patient-controlled analgesia with morphine
MorphineDrug
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Tap Block | Active comparator | the intervention will be tap block after induction of anesthesia with ropivacaine 0,5% 15ml and continuous patient-controlled analgesia with morphine Receives: Procedure: Tap block; Procedure: intravenous Patient controlled analgesia; Drug: Morphine; Drug: Ropivacaine |
| No Tap Block | Active comparator | the patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia Receives: Procedure: intravenous Patient controlled analgesia; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consuption 24 hr after surgery
Cumulative morphine consuption (mg) 24 hr starting from the time of extubation.
Measured: 24 hours
Acute pain after surgery measured with Numerical Rating Scale
patients were assessed for pain, according to Numerical Rating Scale (NRS; 0: no pain to 10: worst pain imaginable)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2017
- Study completionAug 2017
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 Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460640
- Sponsor's protocol ID
- Tap Block
- Status last verified
- Jan 2018
- First submitted
- 19 May 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Covotta M, Claroni C, Costantini M, Torregiani G, Pelagalli L, Zinilli A, Forastiere E. The Effects of Ultrasound-Guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy: A Prospective Randomized Clinical Trial. Pain Med. 2020 Feb 1;21(2):378-386. doi: 10.1093/pm/pnz214.
PubMed 31504875
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound-guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy. A Prospective, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT02460640
- Acronym / sponsor ID
- Tap Block
- Conditions
- Acute Pain, Chronic Pain
- Keywords
- Minimally invasive surgery, Partial nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Jun 2015 (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.
Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tap Block | Active comparator | Procedure: Tap block, Procedure: intravenous Patient controlled analgesia, Drug: Morphine, Drug: Ropivacainethe intervention will be tap block after induction of anesthesia with ropivacaine 0,5% 15ml and continuous patient-controlled analgesia with morphine |
| No Tap Block | Active comparator | Procedure: intravenous Patient controlled analgesia, Drug: Morphinethe patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asa score I,II,II
- patients scheduled for robot assisted partial nephrectomy
Key exclusion criteria (3 listed)
- previous abdominal surgery
- inability to provide informed consent
- allergy to the anesthetic drugs
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 |
|---|---|---|
| Tap blockintravenous patient-controlled analgesia with morphine and tap block with subcostal and posterior approach with ropivacaine 0,5% 15ml+15ml | Procedure or surgery | Tap Block |
| intravenous Patient controlled analgesiaintravenous patient-controlled analgesia with morphine | Procedure or surgery | No Tap Block, Tap Block |
| Morphine | Drug | No Tap Block, Tap Block |
| Ropivacaine | Drug | Tap Block |
Primary outcome
Morphine consuption 24 hr after surgery
Time frame: 24 hours
Cumulative morphine consuption (mg) 24 hr starting from the time of extubation.
Acute pain after surgery measured with Numerical Rating Scale
Time frame: 24 hours
patients were assessed for pain, according to Numerical Rating Scale (NRS; 0: no pain to 10: worst pain imaginable)
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 5 Feb 2018.
- Derived from this study: PubMed 31504875Covotta M, Claroni C, Costantini M, Torregiani G, Pelagalli L, Zinilli A, Forastiere E. The Effects of Ultrasound-Guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy: A Prospective Randomized Clinical Trial. Pain Med. 2020 Feb 1;21(2):378-386. doi: 10.1093/pm/pnz214.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tap block, Morphine and Ropivacaine in people with Acute Pain and Chronic Pain, run by Regina Elena Cancer Institute at 1 site in Italy.
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 3 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 5 Feb 2018. 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 Italy. 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?
Morphine consuption 24 hr after surgery (time frame: 24 hours). The study lists 2 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 NCT02460640, 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 5 Feb 2018.