COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Analgetic Effectiveness of a Lidocaine Loaded Hemostatic, Bioresorbable Putty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504035
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : February 9, 2012
Orthocon, Inc.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Device: Orthostat-L Device: Orthostat Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pelvic Donor Site Pain quantified by the VAS and Wong Baker Pain Rating Scale [ Time Frame: 72 hours after putty administration ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01504035

Layout table for location information
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Orthocon, Inc.
Layout table for investigator information
Principal Investigator: Valderrabano Victor, MD PhD Orthopedic Department, University Hospital Basel, Switzerland
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01504035    
Other Study ID Numbers: ORG 001
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Keywords provided by University Hospital, Basel, Switzerland:
Donor site pain
Iliac crest
Bone graft
Hemostatic putty
Donor site pain following harvest of iliac crest bone grafts