ALICE-Regional Anesthesia in Italy: Complications and Outcomes

Completed

• Conditions: Chronic Pain
• Interventions: Procedure: regional anesthesia; Procedure: non-regional anesthesia

• Registration Number: NCT02147730
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Primary Completion: 2016-05
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Persistent Pain	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).

Secondary Outcome Measures

Name	Time	Method
side effects	6 months	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.
quality of life	6 months	changes in quality of life after surgery will be assessed with a 5-point scale (very inferior, inferior, same of preoperatively, superior, very superior)
functional activity	6 month	expressed as number of days after the intervention before the patient has returned to a normal activity
Patients satisfaction	6 months	Patient satisfaction will be assessed with a verbal rating scale from 0 (completely dissatisfied) to 10 (completely satisfied).

Trial Locations

Locations (1)

Department of Anesthesia and ICU - IRCCS Policlinico S Matteo; 🇮🇹 Pavia, Italy