Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

Not Applicable

Completed

• Conditions: Injury of Anterior Cruciate Ligament
• Interventions: Procedure: Automatic Intermittent Bolus of ropivacaine 0.2%; Procedure: Continuous Infusion of ropivacaine 0.2%

• Registration Number: NCT02589288
• Lead Sponsor: ASST Gaetano Pini-CTO

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-11
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automatic Intermittent Bolus	Automatic Intermittent Bolus of ropivacaine 0.2%	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).
Continuous Infusion	Continuous Infusion of ropivacaine 0.2%	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).

Primary Outcome Measures

Name	Time	Method
NRS Score	72h postoperative	Evaluation of numeric rating score (NRS) in patient with automatic intermittent bolus of Ropivacaine 0,2% instead of classic continuous perfusion

Secondary Outcome Measures

Name	Time	Method
10mt walk test	72h postoperative	time need to walk 10 meters
Opioids request	72h postoperative	Opioids consumption will be recorded throughout 72 postoperative hours
Local anesthetic consumption	72h postoperative	Evaluation of local anesthesia consumption every 6h in first 72 postoperative hours.
Up and Go test	72h postoperative	"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

Trial Locations

Locations (1)

Istituto ortopedico Gaetano Pini; 🇮🇹 Milan, Italy