Analgetic Effectiveness of a Lidocaine Loaded Hemostatic, Bioresorbable Putty

This study has been completed.
Sponsor:
Collaborator:
ORTHOCON Inc.,NY,USA
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01504035
First received: January 2, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

The goal of this study was to test the efficacy of local analgesic (lidocaine) loaded hemostatic putty in reducing donor site pain following the harvest of pelvic bone grafts. In 14 patients undergoing harvest of a pelvic bone graft during foot surgery, the bone defect at the pelvis was either filled with a lidocaine loaded hemostatic putty (Orthostat-L) or the same putty without lidocaine (Orthostat, currently marketed as Hemabsorb). Postoperatively, foot pain was eliminated with a peripheral nerve block, while pelvis pain was quantified with two commonly used pain rating scales (VAS and Wong Baker). Blood samples were collected at regular time intervals to measure lidocaine levels. Patients which received the lidocaine loaded putty experienced significantly less pain during the first 12 hours after surgery as compared to those patients who received the lidocaine deficient putty. Blood lidocaine levels always stayed below the toxic threshold.


Condition Intervention Phase
Pain
Device: Orthostat-L
Device: Orthostat
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Addition of Lidocaine to a Hemostatic, Bioresorbable Putty in the Treatment of Iliac Crest Donor Site Pain

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Pelvic Donor Site Pain quantified by the VAS and Wong Baker Pain Rating Scale [ Time Frame: 72 hours after putty administration ] [ Designated as safety issue: No ]
    Pain scores were plotted over time to either quantify pain at specific time points or to calculate the area under the curve in between two time points as a representative of the overall pain experienced in a specific time intervall.


Enrollment: 14
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemostatic putty plus Lidocaine (Orthostat-L) Device: Orthostat-L
Application of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site
Other Name: Xybrex
Active Comparator: Hemostatic putty (Orthostat) Device: Orthostat
Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site
Other Name: Hemabsorb

Detailed Description:

The harvest of iliac crest bone grafts (ICBG) is associated with relevant donor site pain, but may be lowered by the local application of a biodegradable, hemostatic putty loaded with Lidocaine (=Orthostat-L ™) for sustained local analgesic release. The primary goal of this double-blind controlled trial was to assess the efficacy of the addition of Lidocaine to a hemostatic putty in reducing donor site pain following ICBG in foot and ankle procedures.

In 14 patients undergoing ICBG harvest during a foot and ankle procedure, the bone defect at the iliac crest was either filled with Orthostat-L™ (n=7) or with the same hemostatic putty without Lidocaine (Orthostat ™, n=7; currently marketed as HemasorbTM). Postoperatively, donor site pain was managed by patient controlled morphine delivery while surgical site pain was eliminated by a peripheral nerve block. During the first 72 postoperative hours, donor site pain was quantified every 4 hours using a Visual Analog Scale (VAS) and the Wong Baker FACES pain rating scale. In addition, cumulated morphine doses required by the patients and serum Lidocaine levels were registered. Pain scores were plotted over time to calculate the area under the curve (AUC) as a representative of the overall pain experienced within specific time points.

There were no significant differences in bone graft size, putty amount and cumulated morphine use between the two groups. Orthostat-L™ provided a significant overall harvest site pain reduction over the first 12 hours postoperatively as evidenced by a significant decrease of the AUC in both VAS and Wong Baker FACES pain score plots (p=0.0366 and p = 0.0024, respectively). After 12 hours, pain scores rapidly returned to baseline levels in both groups. Serum Lidocaine consistently remained below the level of toxicity of 6mg/l.

In conclusion, the addition of Lidocaine to a hemostatic putty offers a significant ICBG harvest site pain reduction over the first 12 postoperative hours and appears to be safe in clinical use.

  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient scheduled for a foot and ankle procedure that requires harvest of an iliac crest bone graft
  • Written informed consent
  • No child bearing potential

Exclusion Criteria:

  • History of iliac crest bone graft removal
  • Liver failure
  • Heart failure
  • Mental condition impeding cooperation in the study ( e.g. dementia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504035

Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
ORTHOCON Inc.,NY,USA
Investigators
Principal Investigator: Valderrabano Victor, MD PhD Orthopedic Department, University Hospital Basel, Switzerland
  More Information

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01504035     History of Changes
Other Study ID Numbers: ORG 001
Study First Received: January 2, 2012
Last Updated: February 8, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Donor site pain
Iliac crest
Bone graft
Hemostatic putty
lidocaine
Donor site pain following harvest of iliac crest bone grafts

Additional relevant MeSH terms:
Hemostatics
Lidocaine
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014