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ALICE-Regional Anesthesia in Italy: Complications and Outcomes

I

IRCCS Policlinico S. Matteo

Status

Completed

Conditions

Chronic Pain

Treatments

Procedure: regional anesthesia
Procedure: non-regional anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT02147730
PT-SM-12-Alice

Details and patient eligibility

About

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.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

surgical patients
Description:
all surgical patients undergoing gastrectomy, knee-hip-shoulder arthroplasty, hallux valgus surgery, hernia repair, saphenectomy, cesarean section,colectomy, hysterectomy, nephrectomy mastectomy during study period
Treatment:
Procedure: regional anesthesia
Procedure: non-regional anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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