NCT01504035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

January 2, 2012

Last Update Submit

February 8, 2012

Conditions

Pain

Keywords

Donor site painIliac crestBone graftHemostatic puttylidocaineDonor site pain following harvest of iliac crest bone grafts

Outcome Measures

Primary Outcomes (1)

  • Pelvic Donor Site Pain quantified by the VAS and Wong Baker Pain Rating Scale

    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.

    72 hours after putty administration

Study Arms (2)

Hemostatic putty plus Lidocaine (Orthostat-L)

EXPERIMENTAL
Device: Orthostat-L

Hemostatic putty (Orthostat)

ACTIVE COMPARATOR
Device: Orthostat

Interventions

Orthostat-LDEVICE

Application of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site

Also known as: Xybrex
Hemostatic putty plus Lidocaine (Orthostat-L)
OrthostatDEVICE

Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site

Also known as: Hemabsorb
Hemostatic putty (Orthostat)

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of iliac crest bone graft removal
  • Liver failure
  • Heart failure
  • Mental condition impeding cooperation in the study ( e.g. dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (3)

  • Wang CF, Djalali AG, Gandhi A, Knaack D, De Girolami U, Strichartz G, Gerner P. An absorbable local anesthetic matrix provides several days of functional sciatic nerve blockade. Anesth Analg. 2009 Mar;108(3):1027-33. doi: 10.1213/ane.0b013e318193596a.

    PMID: 19224820BACKGROUND

  • Wang CF, Pancaro C, Gerner P, Strichartz G. Prolonged suppression of postincisional pain by a slow-release formulation of lidocaine. Anesthesiology. 2011 Jan;114(1):135-49. doi: 10.1097/ALN.0b013e3182001996.

    PMID: 21169797BACKGROUND

  • Muller MA, Mehrkens A, Zurcher R, Vavken P, Valderrabano V. Effectiveness of the addition of Lidocaine to a hemostatic, bioresorbable putty in the treatment of iliac crest donor site pain. BMC Musculoskelet Disord. 2014 Dec 8;15:415. doi: 10.1186/1471-2474-15-415.

    PMID: 25482244DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valderrabano Victor, MD PhD

    Orthopedic Department, University Hospital Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

May 1, 2008

Primary Completion

July 1, 2008

Study Completion

November 1, 2008

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

CH(1)