Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery

This study is currently recruiting participants.
Verified December 2013 by Wake Forest School of Medicine
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
Robert Weller, M.D., Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01167907
First received: July 21, 2010
Last updated: December 4, 2013
Last verified: December 2013

July 21, 2010
December 4, 2013
July 2010
July 2014   (final data collection date for primary outcome measure)
Verbal pain scores [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved.
Same as current
Complete list of historical versions of study NCT01167907 on ClinicalTrials.gov Archive Site
  • Opioid use [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of opioid use will be evaluated.
  • nausea [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of nausea will be evaluated.
  • vomiting [ Time Frame: 48 hour post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of vomiting will be evaluated.
  • sleep disturbance [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of sleep disturbance (as number of wakenings) will be evaluated.
  • Reduction of quadriceps strength [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of quadricept strength will be evaluated.
  • Opioid use [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of opioid use will be evaluated.
  • nausea [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of nausea will be evaluated.
  • vomiting [ Time Frame: 48 hour post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of vomiting will be evaluated.
  • sleep disturbance [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of sleep disturbance (as number of wakenings) will be evaluated.
  • Reduction of quadricepts strength [ Time Frame: 48 hours post nerve blockade ] [ Designated as safety issue: No ]
    Secondary endpoints of reduction of quadricept strength will be evaluated.
Not Provided
Not Provided
 
Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery
Evaluation of a Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block for Postoperative Analgesia Following Ankle Surgery

A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve.

The purpose of this research study is to test whether the placement of a second nerve block catheter, rather than a single injection for the saphenous nerve block will improve pain relief and/or reduce pain medication needed after surgery enough to justify two nerve block catheters.

There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake Forest University typically have a nerve block catheter placed next to the sciatic nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of local anesthetic is usually performed to block the saphenous nerve for 12-16 hours postoperatively.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Orthopedic Surgery of Lower Extremity
  • Drug: 0.2% ropivacaine
    0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
    Other Name: NAROPIN®
  • Drug: saline
    saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
  • Experimental: 0.2% ropivacaine
    Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.
    Interventions:
    • Drug: 0.2% ropivacaine
    • Drug: saline
  • Placebo Comparator: Saline
    Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • surgery for unilateral ankle arthrodesis
  • surgery for open reduction and internal fixation of bi/tri malleolar fracture

Exclusion Criteria:

  • coagulation abnormalities
  • history of opioid addiction
  • current chronic pain therapy with high dsoe opioid
  • allergy to study medication
  • failure of the sciatic nerve catheter
Both
18 Years to 75 Years
No
Contact: Regina Curry, RN 336-716-4294 recurry@wfubmc.edu
United States
 
NCT01167907
Protocol WFUHS 00013823
No
Robert Weller, M.D., Wake Forest School of Medicine
Wake Forest School of Medicine
I-Flow
Principal Investigator: Robert Weller, M.D. Wake Forest Univesity Health Sciences
Wake Forest School of Medicine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP