Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

NCT02589288 | Completed

• 1 other identifier: IOGPGC09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.

Conditions

Injury of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

• NRS Score

  Evaluation of numeric rating score (NRS) in patient with automatic intermittent bolus of Ropivacaine 0,2% instead of classic continuous perfusion

  72h postoperative

Secondary Outcomes (4)

• Up and Go test

  72h postoperative

• Opioids request

  72h postoperative

• Local anesthetic consumption

  72h postoperative

• 10mt walk test

  72h postoperative

Study Arms (2)

Continuous Infusion

ACTIVE COMPARATOR

Patients receive a postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Procedure: Continuous Infusion of ropivacaine 0.2%

Automatic Intermittent Bolus

EXPERIMENTAL

Patients receive a postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% and 4 ml PCA bolus, lockout 20 minutes every hour via electronic infusion pump (Micrel device, Greece).

Procedure: Automatic Intermittent Bolus of ropivacaine 0.2%

Interventions

Continuous Infusion of ropivacaine 0.2% PROCEDURE

Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Also known as: naropine 0.2%

Continuous Infusion

Automatic Intermittent Bolus of ropivacaine 0.2% PROCEDURE

Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).

Automatic Intermittent Bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years old
• American society of anesthesiology (ASA) physical status I-II
• Signed informed consensus

You may not qualify if:

• ASA \>II
• Unstable neurological disease
• Diabetic mellitus (DM) type I-II
• Allergy to used drugs
• Opioid chronic treatment
• Consensus refusal or not valid
• Anticoagulant therapy
• Postoperative intensive care required

Sponsors & Collaborators

• ASST Gaetano Pini-CTO: lead

Study Sites (1)

Istituto ortopedico Gaetano Pini

Milan, Italy

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Gianluca Cappelleri, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

IT (1)