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NCT Number: NCT02147730

ALICE-Regional Anesthesia in Italy: Complications and Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesia and ICU - IRCCS Policlinico S Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional Anesthesia

Procedure

all patients receiving a regional anesthesia/analgesia technique

non-regional anesthesia

Procedure

all patients receiving other-than-regional anesthesia techniques

Primary outcomes

  1. Persistent Pain

    Time frame: 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 outcomes

  1. Patients satisfaction

    Time frame: 6 months

    Patient satisfaction will be assessed with a verbal rating scale from 0 (completely dissatisfied) to 10 (completely satisfied).

  2. quality of life

    Time frame: 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)

  3. side effects

    Time frame: 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.

  4. functional activity

    Time frame: 6 month

    expressed as number of days after the intervention before the patient has returned to a normal activity

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: ALICE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 28, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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