ALICE-Regional Anesthesia in Italy: Complications and Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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ALICE-Regional Anesthesia in Italy: Complications and Outcomes

Conditions
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Chronic Pain

Intervention / Treatment
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* Procedure: regional anesthesia
* Procedure: non-regional anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgical patients<br>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<br>* all patients receiving a regional anesthesia/analgesia technique<br>Procedure: non-regional anesthesia<br>* all patients receiving other-than-regional anesthesia techniques<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain