Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

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

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.

Study Overview

• Status: Completed
• Conditions: Injury of Anterior Cruciate Ligament
• Intervention / Treatment: Procedure: Continuous Infusion of ropivacaine 0.2%; Procedure: Automatic Intermittent Bolus of ropivacaine 0.2%

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Istituto Ortopedico Gaetano Pini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Infusion; 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%; 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).; Other Names: naropine 0.2%
Experimental: Automatic Intermittent Bolus; 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%; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72h postoperative
Opioids request	Opioids consumption will be recorded throughout 72 postoperative hours	72h postoperative
Local anesthetic consumption	Evaluation of local anesthesia consumption every 6h in first 72 postoperative hours.	72h postoperative
10mt walk test	time need to walk 10 meters	72h postoperative

Collaborators and Investigators

• Sponsor: ASST Gaetano Pini-CTO
• Investigators: Principal Investigator: Gianluca Cappelleri, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IOGPGC09