PainPhase 2/3NCT01504035
Analgetic Effectiveness of a Lidocaine Loaded Hemostatic, Bioresorbable Putty
A Phase 2/3 study testing Orthostat-L and Orthostat in people with Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Pain
- What is being tested?
- Orthostat-L and Orthostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Nov 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for a foot and ankle procedure that requires harvest of an iliac crest bone graft
- Written informed consent
- No child bearing potential
Who cannot join
- History of iliac crest bone graft removal
- Liver failure
- Heart failure
- Mental condition impeding cooperation in the study ( e.g. dementia)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Effectiveness of the Addition of Lidocaine to a Hemostatic, Bioresorbable Putty in the Treatment of Iliac Crest Donor Site Pain
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Orthostat-L, Orthostat
- Keywords
- Donor site pain, Iliac crest, Bone graft, Hemostatic putty, lidocaine, Donor site pain following harvest of iliac crest bone grafts
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthostat-LDevice
Also called Xybrex
Application of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site
OrthostatDevice
Also called Hemabsorb
Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site
| Study group | Role | What they receive |
|---|---|---|
| Hemostatic putty plus Lidocaine (Orthostat-L) | Experimental | Not described Receives: Device: Orthostat-L |
| Hemostatic putty (Orthostat) | Active comparator | Not described Receives: Device: Orthostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after putty administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Orthocon, Inc.
- Responsible party
- Sponsor
- Investigators
- Valderrabano Victor, MD PhD, Principal investigator, Orthopedic Department, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504035
- Sponsor's protocol ID
- ORG 001
- Status last verified
- Feb 2012
- First submitted
- 2 Jan 2012
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19224820Wang 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.
PubMed 21169797Muller 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.
PubMed 25482244
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Addition of Lidocaine to a Hemostatic, Bioresorbable Putty in the Treatment of Iliac Crest Donor Site Pain
- ClinicalTrials.gov ID
- NCT01504035
- Acronym / sponsor ID
- ORG 001
- Conditions
- Pain
- Keywords
- Donor site pain, Iliac crest, Bone graft, Hemostatic putty, lidocaine, Donor site pain following harvest of iliac crest bone grafts
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Orthocon, Inc.
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemostatic putty plus Lidocaine (Orthostat-L) | Experimental | Device: Orthostat-L |
| Hemostatic putty (Orthostat) | Active comparator | Device: Orthostat |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for a foot and ankle procedure that requires harvest of an iliac crest bone graft
- Written informed consent
- No child bearing potential
Key exclusion criteria (4 listed)
- History of iliac crest bone graft removal
- Liver failure
- Heart failure
- Mental condition impeding cooperation in the study ( e.g. dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthostat-LAlso: XybrexApplication of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site | Device | Hemostatic putty plus Lidocaine (Orthostat-L) |
| OrthostatAlso: HemabsorbApplication of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site | Device | Hemostatic putty (Orthostat) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Background: PubMed 19224820Wang 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.
- Background: PubMed 21169797Wang 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.
- Derived from this study: PubMed 25482244Muller 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valderrabano Victor, MD PhD principal investigator
Orthopedic Department, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Orthostat-L and Orthostat in people with Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Donor Site Pain quantified by the VAS and Wong Baker Pain Rating Scale (time frame: 72 hours after putty administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.