PainNCT01466764
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
A study testing Anakinra and Normal Saline in people with Pain and Inflammation, run by Stanford University at 1 site in United States.
Trial summary
The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Inflammation
- What is being tested?
- Anakinra and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.
Who cannot join
- Patients will be excluded from participation if they have one or more of the following conditions:
- Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count > 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source
- End-stage renal disease
- A history of diabetic neuropathy
- A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
- Leukopenia (white blood cell count < 2,000/ul)
Show all 10Show fewer
- Thrombocytopenia (platelet count < 100,000/ul)
- Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
- A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.
Read the detailed description
This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures. The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery). The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators. The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.
- Conditions
- Pain, Inflammation
- Being tested
- Anakinra, Normal Saline
- Keywords
- biomarkers
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
Normal SalineOther
Also called No other name
An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Active comparator | Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. Receives: Drug: Anakinra |
| Saline injection | Placebo comparator | Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1
Measured: Up to 72 hours following surgery
Secondary outcomes (6)
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study.
PCA/IV: Patient controlled Analgesia/ Intravenous
Measured: Up to 72 hours following surgery
Post-operative Pain Intensity
Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)
Measured: Up to 72 hours following surgery
Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.
Measured: Up to 72 hours following surgery plus 3 weeks follow-up
Count of Participants With Venous Thrombosis After Surgery During Hospitalization
Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.
Measured: Up to 72 hours following surgery plus 3 weeks follow-up
Assess Rates of Wound Dehiscence
Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.
Measured: Up to 72 hours following surgery plus 3 weeks follow-up
Total Length of Hospital Stay
Total length of hospital stay for patients enrolled in the study.
Measured: Up to approximately 5 days maximum (admittance to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2013
- Study completionJun 2013
Why it stopped: Due to inability to demonstrate benefit in this patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Peltz, Stanford University
- Investigators
- Robert L Lobato, MD, Principal investigator, Stanford U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466764
- Sponsor's protocol ID
- SU-10312011-8587
- Status last verified
- Jul 2017
- First submitted
- 1 Nov 2011
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
- ClinicalTrials.gov ID
- NCT01466764
- Acronym / sponsor ID
- SU-10312011-8587
- Conditions
- Pain, Inflammation
- Keywords
- biomarkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to inability to demonstrate benefit in this patient population.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 6 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.
Detailed description
This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures. The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery). The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators. The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Active comparator | Drug: AnakinraTwo subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. |
| Saline injection | Placebo comparator | Other: Normal SalineTwo subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.
Key exclusion criteria (10 listed)
- Patients will be excluded from participation if they have one or more of the following conditions:
- Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count > 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source
- End-stage renal disease
- A history of diabetic neuropathy
- A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
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 |
|---|---|---|
| AnakinraAlso: KineretAn injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery. | Drug | Anakinra |
| Normal SalineAlso: No other nameAn injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery. | Other | Saline injection |
Primary outcome
Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
Time frame: Up to 72 hours following surgery
Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1
6 secondary outcomes
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
Time frame: Up to 72 hours following surgery
Post-operative Pain Intensity
Time frame: Up to 72 hours following surgery
Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
Time frame: Up to 72 hours following surgery plus 3 weeks follow-up
Count of Participants With Venous Thrombosis After Surgery During Hospitalization
Time frame: Up to 72 hours following surgery plus 3 weeks follow-up
Assess Rates of Wound Dehiscence
Time frame: Up to 72 hours following surgery plus 3 weeks follow-up
Total Length of Hospital Stay
Time frame: Up to approximately 5 days maximum (admittance to discharge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert L Lobato, MD principal investigator
Stanford U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anakinra and Normal Saline in people with Pain and Inflammation, run by Stanford University at 1 site in United States.
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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 9 Aug 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra. (time frame: Up to 72 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.