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Other Reconstructive Surgery | Clonidine in Femoral Nerve Block Surgery in Children

Other Reconstructive Surgery research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Other Reconstructive Surgery

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ropivacaineropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Drug:Clonidineclonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ropivacaine plus clonidineRopivacaine plus clonidine for femoral block

RopivacaineRopivacaine alone for femoral block

Study Status

Withdrawn

Start Date: April 2011

Completed Date: March 2013

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Pain

Secondary Outcome: Heart rate

Study sponsors, principal investigator, and references

Principal Investigator: Amod Sawardekar, MD

Lead Sponsor: Nationwide Children's Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01293149

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