Clonidine in Femoral Nerve Block Surgery in Children

Other Reconstructive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01293149
• Other study ID #: IRB11-00075
• Status: Withdrawn
• Phase: Phase 2
• First received: February 9, 2011
• Last updated: May 6, 2015
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Other Reconstructive Surgery

Intervention

Drug:
• Ropivacaine
ropivacaine 0.2% 0.5 ml/kg (max 20 ml)
• Clonidine
clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Heart rate		15, 30 & 60 mins. post-op	Yes
Secondary	Blood pressure		15, 30 & 60 mins. post-op	Yes
Secondary	Oxygen saturation		15, 30 & 60 mins. post-op	Yes