Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

Injury of Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589288
• Other study ID #: IOGPGC09
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: August 11, 2017
• Start date: November 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injury of Anterior Cruciate Ligament

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Istituto ortopedico Gaetano Pini	Milan

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

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