Clinical trial NCT02147730: ALICE-Regional Anesthesia in Italy: Complications and Outcomes
Official title: ALICE-Regional Anesthesia in Italy: Complications and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: chronic pain
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* more than 18 ys old
* informed consent

Exclusion Criteria:

* reintervention
* ASA (American Society of Anesthesiologists) status 4 and 5
* emergency surgery
* no informed consent

Primary outcomes:
measure: Persistent Pain
timeFrame: 6 months
Secondary outcomes:
measure: Patients satisfaction
timeFrame: 6 months
measure: quality of life
timeFrame: 6 months
measure: side effects
timeFrame: 6 months
measure: functional activity
timeFrame: 6 month
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Department of Anesthesia and ICU - IRCCS Policlinico S Matteo
Study officials:
References:
citation: 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.