ALICE-Regional Anesthesia in Italy: Complications and Outcomes

NCT ID: NCT02147730

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

regional anesthesia

Intervention Type: PROCEDURE

all patients receiving a regional anesthesia/analgesia technique

non-regional anesthesia

Intervention Type: PROCEDURE

all patients receiving other-than-regional anesthesia techniques

Interventions

regional anesthesia

all patients receiving a regional anesthesia/analgesia technique

Intervention Type: PROCEDURE

non-regional anesthesia

all patients receiving other-than-regional anesthesia techniques

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Massimo Allegri

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesia and ICU - IRCCS Policlinico S Matteo

Pavia, Pavia, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28767456 (View on PubMed)

Other Identifiers

PT-SM-12-Alice

Identifier Type: -

Identifier Source: org_study_id