Clonidine in Femoral Nerve Block Surgery in Children

Condition(s) targeted: Other Reconstructive Surgery

Intervention: Ropivacaine (Drug); Clonidine (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Nationwide Children's Hospital

Official(s) and/or principal investigator(s):
Amod Sawardekar, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain

Secondary outcome:

Heart rate

Blood pressure

Oxygen saturation

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

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

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

Starting date: April 2011
Last updated: May 6, 2015