Analgetic Effectiveness of a Lidocaine Loaded Hemostatic, Bioresorbable Putty
|ClinicalTrials.gov Identifier: NCT01504035|
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Orthostat-L Device: Orthostat||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||July 2008|
|Study Completion Date :||November 2008|
|Experimental: Hemostatic putty plus Lidocaine (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)||
Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site
Other Name: Hemabsorb
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504035
|University Hospital Basel|
|Basel, Basel-Stadt, Switzerland, 4031|
|Principal Investigator:||Valderrabano Victor, MD PhD||Orthopedic Department, University Hospital Basel, Switzerland|