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Clonidine in Femoral Nerve Block Surgery in Children

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01293149
Enrollment
0
Registered
2011-02-10
Start date
2011-04-30
Completion date
2013-03-31
Last updated
2015-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Reconstructive Surgery

Keywords

knee, reconstructive surgery, femoral nerve block

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.

Interventions

DRUGRopivacaine

ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

DRUGClonidine

clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain24 hoursThe 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.

Secondary

MeasureTime frame
Heart rate15, 30 & 60 mins. post-op
Blood pressure15, 30 & 60 mins. post-op
Oxygen saturation15, 30 & 60 mins. post-op

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026