Back to results

Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

Primary Purpose

Injury of Anterior Cruciate Ligament

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Continuous Infusion of ropivacaine 0.2%

Automatic Intermittent Bolus of ropivacaine 0.2%

About this trial

This is an interventional treatment trial for Injury of Anterior Cruciate Ligament

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Istituto ortopedico Gaetano Pini

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Infusion

Automatic Intermittent Bolus

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

NRS Score

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

Secondary Outcome Measures

Up and Go test

"up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair

Opioids request

Opioids consumption will be recorded throughout 72 postoperative hours

Local anesthetic consumption

Evaluation of local anesthesia consumption every 6h in first 72 postoperative hours.

10mt walk test

time need to walk 10 meters

Full Information

NCT ID

NCT02589288

First Posted

October 27, 2015

Last Updated

August 11, 2017

Sponsor

ASST Gaetano Pini-CTO

1. Study Identification

Unique Protocol Identification Number

NCT02589288

Brief Title

Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

Official Title

Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus For Postoperative Analgesia After Day-Case Anterior Cruciate Ligament Reconstruction

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

ASST Gaetano Pini-CTO

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Injury of Anterior Cruciate Ligament

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Infusion

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Automatic Intermittent Bolus

Arm Type

Experimental

Arm Description

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).

Intervention Type

Procedure

Intervention Name(s)

Continuous Infusion of ropivacaine 0.2%

Other Intervention Name(s)

naropine 0.2%

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Automatic Intermittent Bolus of ropivacaine 0.2%

Intervention Description

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).

Primary Outcome Measure Information:

Title

NRS Score

Description

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

Time Frame

72h postoperative

Secondary Outcome Measure Information:

Title

Up and Go test

Description

"up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair

Time Frame

72h postoperative

Title

Opioids request

Description

Opioids consumption will be recorded throughout 72 postoperative hours

Time Frame

72h postoperative

Title

Local anesthetic consumption

Description

Evaluation of local anesthesia consumption every 6h in first 72 postoperative hours.

Time Frame

72h postoperative

Title

10mt walk test

Description

time need to walk 10 meters

Time Frame

72h postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gianluca Cappelleri, MD

Organizational Affiliation

Study Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto ortopedico Gaetano Pini

City

Milan

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

We'll reach out to this number within 24 hrs