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Clinical Trials/NCT01293149
NCT01293149WithdrawnPhase 2

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

Nationwide Children's Hospital1 site in 1 countryStarted: April 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Locations
1
Primary Endpoint
Pain

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
— to 21 Years (Child, Adult)
Sex
All
Accepts 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

Arms & Interventions

Ropivacaine plus clonidine

Experimental

Ropivacaine plus clonidine for femoral block

Intervention: Clonidine (Drug)

Ropivacaine

Active Comparator

Ropivacaine alone for femoral block

Intervention: Ropivacaine (Drug)

Outcomes

Primary Outcomes

Pain

Time Frame: 24 hours

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.

Secondary Outcomes

  • Blood pressure(15, 30 & 60 mins. post-op)
  • Oxygen saturation(15, 30 & 60 mins. post-op)
  • Heart rate(15, 30 & 60 mins. post-op)

Investigators

Sponsor Class
Other

Study Sites (1)

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