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
  Purpose

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.


Condition Intervention
Orthopedic Surgery of Lower Extremity
Drug: 0.2% ropivacaine
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block for Postoperative Analgesia Following Ankle Surgery

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 74
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: saline
saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167907

Contacts
Contact: Regina Curry, RN 336-716-4294 recurry@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Robert Weller, M.D.         
Sub-Investigator: Daryl Henshaw, M.D.         
Sponsors and Collaborators
Wake Forest School of Medicine
I-Flow
Investigators
Principal Investigator: Robert Weller, M.D. Wake Forest Univesity Health Sciences
  More Information

No publications provided

Responsible Party: Robert Weller, M.D., Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01167907     History of Changes
Other Study ID Numbers: Protocol WFUHS 00013823
Study First Received: July 21, 2010
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
ankle
arthrodesis
internal fixation
bi/tri malleolar fracture

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014