Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

NCT02589288 — Not applicable, Completed, 80 participants, ASST Gaetano Pini-CTO

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

Registry	NCT02589288
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Actual)
Sponsor	ASST Gaetano Pini-CTO (Other)
Conditions	Injury of Anterior Cruciate Ligament
Interventions	Continuous Infusion of ropivacaine 0.2%, Automatic Intermittent Bolus of ropivacaine 0.2% (Procedure)
Dates	start 2015-11-01, primary completion 2016-12-01, completion 2017-03-01, first posted 2015-10-28, last updated 2017-08-14
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Continuous Infusion	Active comparator	Procedure: 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).
Automatic Intermittent Bolus	Experimental	Procedure: 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 of ropivacaine 0.2% (Procedure), also known as naropine 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% (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).

+Outcome measures

Primary outcomes

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 outcomes

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
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.
10mt walk test [72h postoperative]: time need to walk 10 meters

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Istituto ortopedico Gaetano Pini	Milan	Italy

+Investigators

Gianluca Cappelleri, MD, Principal investigator, Study Principal Investigator