ALICE-Regional Anesthesia in Italy: Complications and Outcomes

Chronic Pain Clinical Trial

— ALICE  

Official title:

ALICE-Regional Anesthesia in Italy: Complications and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147730
• Other study ID #: PT-SM-12-Alice
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: March 1, 2017
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Procedure:
• regional anesthesia
all patients receiving a regional anesthesia/analgesia technique
• non-regional anesthesia
all patients receiving other-than-regional anesthesia techniques

Locations

Country	Name	City	State
Italy	Department of Anesthesia and ICU - IRCCS Policlinico S Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

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