Chronic PainALICENCT02147730
ALICE-Regional Anesthesia in Italy: Complications and Outcomes
An observational study of Chronic Pain, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Regional anesthesia techniques, with administration of local anesthetics for neuraxial or peripheral route are now playing a central role in modern anesthesia and in particular in the control of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- regional anesthesia and non-regional anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Sep 2016
- How long will I take part?
- 3 Years
- 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: all surgical patients undergoing gastrectomy, knee-hip-shoulder arthroplasty, allux valgus surgery, hernia repair, safenectomy, cesarean section,colectomy, hysterectomy, nephrectomy mastectomy during study period
Who may be able to join
- more than 18 ys old
- informed consent
Who cannot join
- reintervention
- ASA (American Society of Anesthesiologists) status 4 and 5
- emergency surgery
- no informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Anesthesia and ICU - IRCCS Policlinico S Matteo
Pavia, Pavia, 27100
About this study
Regional anesthesia techniques, with administration of local anesthetics for neuraxial or peripheral route are now playing a central role in modern anesthesia and in particular in the control of postoperative pain. There are many review and meta-analyzes suggesting that a good pain control, and specifically loco regional analgesia, may improve the outcome of patients undergoing surgery.
The control of acute post-operative pain is not the only challenge to be paid by anesthesiologists, because there is still much to be understood in relation to persistent post-surgical pain (PPP), and about the degree of influence that regional anesthesia plays in complete long-term functional recovery of patients.
Read more
From the pathophysiological perspective there is not a precise definition of the mechanisms and risk factors that determine the onset of the persistent pain after surgery, but, more in general, it seems to be related to a malfunction of the mechanism of secondary hyperalgesia.
Regional anesthesia could play a key role, as the main determinant of chronic pain is acute post-operative pain. The techniques of regional anesthesia exert a powerful block at the peripheral level, potentially preventing the progression of central pain and the persistence of stimuli that can reach the central nervous system. In addition, during surgery, these techniques can reduce the metabolic alterations and the triggering mechanisms of local and systemic pro-inflammatory mediators' release.
Few perspective studies exist about the influence of regional anesthesia on long-term outcome and persistent pain after surgery.
The objective of the investigators study is to assess in a prospective fashion the role of regional anesthesia/analgesia technique in preventing (or not) persistence pain occurrence after surgical interventions which are mostly associated to pain persistence, and understand if regional anesthesia provides advantages in other post-surgical outcomes.
- Conditions
- Chronic Pain
- Being tested
- regional anesthesia, non-regional anesthesia
- Keywords
- chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaProcedure or surgery
all patients receiving a regional anesthesia/analgesia technique
non-regional anesthesiaProcedure or surgery
all patients receiving other-than-regional anesthesia techniques
| Study group | Role | What they receive |
|---|---|---|
| surgical patients | all surgical patients undergoing gastrectomy, knee-hip-shoulder arthroplasty, hallux valgus surgery, hernia repair, saphenectomy, cesarean section,colectomy, hysterectomy, nephrectomy mastectomy during study period Receives: Procedure: regional anesthesia; Procedure: non-regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Pain
prevalence of pain at 6 months after surgery. Pain will be assessed with NRS (Numeric Rating Scale) from 0 (no pain) to 10 (worst pain possible).
Measured: 6 months
Secondary outcomes (4)
Patients satisfaction
Patient satisfaction will be assessed with a verbal rating scale from 0 (completely dissatisfied) to 10 (completely satisfied).
Measured: 6 months
quality of life
changes in quality of life after surgery will be assessed with a 5-point scale (very inferior, inferior, same of preoperatively, superior, very superior)
Measured: 6 months
side effects
infection (local or systemic), postoperative neurologic symptoms, thrombotic events, post-dural puncture headache, postoperative nausea and vomiting, perforation/leakage, respiratory failure, heart failure, reintervention, death.
Measured: 6 months
functional activity
expressed as number of days after the intervention before the patient has returned to a normal activity
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionSep 2016
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 Chronic PainStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Allegri, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147730
- Sponsor's protocol ID
- PT-SM-12-Alice
- Acronym
- ALICE
- Status last verified
- Mar 2017
- First submitted
- 1 Apr 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bugada D, Allegri M, Gemma M, Ambrosoli AL, Gazzerro G, Chiumiento F, Dongu D, Nobili F, Fanelli A, Ferrua P, Berruto M, Cappelleri G. Effects of anaesthesia and analgesia on long-term outcome after total knee replacement: A prospective, observational, multicentre study. Eur J Anaesthesiol. 2017 Oct;34(10):665-672. doi: 10.1097/EJA.0000000000000656.
PubMed 28767456
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALICE-Regional Anesthesia in Italy: Complications and Outcomes
- ClinicalTrials.gov ID
- NCT02147730
- Acronym / sponsor ID
- ALICE / PT-SM-12-Alice
- Conditions
- Chronic Pain
- Keywords
- chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 May 2014 (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.
Regional anesthesia techniques, with administration of local anesthetics for neuraxial or peripheral route are now playing a central role in modern anesthesia and in particular in the control of postoperative pain. There are many review and meta-analyzes suggesting that a good pain control, and specifically loco regional analgesia, may improve the outcome of patients undergoing surgery.
The control of acute post-operative pain is not the only challenge to be paid by anesthesiologists, because there is still much to be understood in relation to persistent post-surgical pain (PPP), and about the degree of influence that regional anesthesia plays in complete long-term functional recovery of patients.
From the pathophysiological perspective there is not a precise definition of the mechanisms and risk factors that determine the onset of the persistent pain after surgery, but, more in general, it seems to be related to a malfunction of the mechanism of secondary hyperalgesia.
Regional anesthesia could play a key role, as the main determinant of chronic pain is acute post-operative pain. The techniques of regional anesthesia exert a powerful block at the peripheral level, potentially preventing the progression of central pain and the persistence of stimuli that can reach the central nervous system. In addition, during surgery, these techniques can reduce the metabolic alterations and the triggering mechanisms of local and systemic pro-inflammatory mediators' release.
Few perspective studies exist about the influence of regional anesthesia on long-term outcome and persistent pain after surgery.
The objective of the investigators study is to assess in a prospective fashion the role of regional anesthesia/analgesia technique in preventing (or not) persistence pain occurrence after surgical interventions which are mostly associated to pain persistence, and understand if regional anesthesia provides advantages in other post-surgical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical patients | – | Procedure: regional anesthesia, Procedure: non-regional anesthesiaall surgical patients undergoing gastrectomy, knee-hip-shoulder arthroplasty, hallux valgus surgery, hernia repair, saphenectomy, cesarean section,colectomy, hysterectomy, nephrectomy mastectomy during study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all surgical patients undergoing gastrectomy, knee-hip-shoulder arthroplasty, allux valgus surgery, hernia repair, safenectomy, cesarean section,colectomy, hysterectomy, nephrectomy mastectomy during study period
Key inclusion criteria (2 listed)
- more than 18 ys old
- informed consent
Key exclusion criteria (4 listed)
- reintervention
- ASA (American Society of Anesthesiologists) status 4 and 5
- emergency surgery
- no informed consent
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 |
|---|---|---|
| regional anesthesiaall patients receiving a regional anesthesia/analgesia technique | Procedure or surgery | surgical patients |
| non-regional anesthesiaall patients receiving other-than-regional anesthesia techniques | Procedure or surgery | surgical patients |
Primary outcome
Persistent Pain
Time frame: 6 months
prevalence of pain at 6 months after surgery. Pain will be assessed with NRS (Numeric Rating Scale) from 0 (no pain) to 10 (worst pain possible).
4 secondary outcomes
Patients satisfaction
Time frame: 6 months
quality of life
Time frame: 6 months
side effects
Time frame: 6 months
functional activity
Time frame: 6 month
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 3 Mar 2017.
- Derived from this study: PubMed 28767456Bugada D, Allegri M, Gemma M, Ambrosoli AL, Gazzerro G, Chiumiento F, Dongu D, Nobili F, Fanelli A, Ferrua P, Berruto M, Cappelleri G. Effects of anaesthesia and analgesia on long-term outcome after total knee replacement: A prospective, observational, multicentre study. Eur J Anaesthesiol. 2017 Oct;34(10):665-672. doi: 10.1097/EJA.0000000000000656.
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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?
An observational study of Chronic Pain, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 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 3 Mar 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 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?
Persistent Pain (time frame: 6 months). 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 NCT02147730, 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 3 Mar 2017.