Clonidine in Femoral Nerve Block Surgery in Children

Study Overview
=================
Brief Summary
-----------------
Knee arthroscopy is a common surgical procedure in pediatrics in which the knee joint is visualized through a small camera to help diagnose and treat knee problems. This procedure is commonly accomplished with the use of general anesthesia. Regional anesthesia is commonly completed with a single injection of local anesthetic around the femoral nerve to provide pain relief for several hours following knee arthroscopy. The intent of this study is to examine the effects of clonidine in addition to local anesthetics for femoral nerve blockade in providing children and adolescents post-operative analgesia. The investigators hypothesize the addition of low dose clonidine (1 mcg/kg) provides an additional 4 hours of post operative analgesia following arthroscopic knee surgery and reduces post-operative opiate requirement.

Official Title
-----------------
The Effects of Clonidine on Postoperative Analgesia After Single Shot Femoral Nerve Block Following Arthroscopic Knee Surgery in Children

Conditions
-----------------
Other Reconstructive Surgery

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) functional status I or II Patients scheduled for arthroscopic knee surgery only Exclusion Criteria: Patients with history of chronic opioid therapy, central or peripheral neuropathy, contraindications to regional anesthesia, history of allergy to clonidine or ropivicaine, or anterior cruciate ligament reconstructive surgery in addition to knee arthroscopy

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine plus clonidine<br>Ropivacaine plus clonidine for femoral block | Drug: Clonidine<br>* clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)<br>|
| Active Comparator: Ropivacaine<br>Ropivacaine alone for femoral block | Drug: Ropivacaine<br>* ropivacaine 0.2% 0.5 ml/kg (max 20 ml)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | The primary end-point of the study is time from performance of femoral nerve block to onset of pain in the distribution of the femoral nerve. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 15, 30 & 60 mins. post-op | 
| Blood pressure |  | 15, 30 & 60 mins. post-op | 
| Oxygen saturation |  | 15, 30 & 60 mins. post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee, reconstructive surgery, femoral nerve block