Analgetic Effectiveness of a Lidocaine Loaded Hemostatic, Bioresorbable Putty
Condition: Pain
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Orthostat-L; Orthostat
Intervention type(s): Device; Device
Intervention description(s): Application of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site; Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site
Other intervention name(s): Xybrex; Hemabsorb
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Donor site pain; Iliac crest; Bone graft; Hemostatic putty; lidocaine; Donor site pain following harvest of iliac crest bone grafts