ALICE-Regional Anesthesia in Italy: Complications and Outcomes (ALICE)

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: regional anesthesia; Procedure: non-regional anesthesia

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Department of Anesthesia and ICU - IRCCS Policlinico S Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: regional anesthesia; all patients receiving a regional anesthesia/analgesia technique; Procedure: non-regional anesthesia; all patients receiving other-than-regional anesthesia techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients satisfaction	Patient satisfaction will be assessed with a verbal rating scale from 0 (completely dissatisfied) to 10 (completely satisfied).	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)	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.	6 months
functional activity	expressed as number of days after the intervention before the patient has returned to a normal activity	6 month

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: PT-SM-12-Alice