NCT02147730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

April 1, 2014

Last Update Submit

March 1, 2017

Conditions

Chronic Pain

Keywords

chronic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patients satisfaction

    6 months

  • quality of life

    6 months

  • side effects

    6 months

  • functional activity

    6 month

Study Arms (1)

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 anesthesiaProcedure: non-regional anesthesia

Interventions

regional anesthesiaPROCEDURE

all patients receiving a regional anesthesia/analgesia technique

surgical patients
non-regional anesthesiaPROCEDURE

all patients receiving other-than-regional anesthesia techniques

surgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • more than 18 ys old
  • informed consent

You may not qualify if:

  • reintervention
  • ASA (American Society of Anesthesiologists) status 4 and 5
  • emergency surgery
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia and ICU - IRCCS Policlinico S Matteo

Pavia, Pavia, 27100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 28767456DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 1, 2014

First Posted

May 28, 2014

Study Start

January 1, 2013

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

IT(1)