Trial Outcomes & Findings for Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain (NCT NCT01466764)
NCT ID: NCT01466764
Last Updated: 2017-08-09
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Up to 72 hours following surgery
Results posted on
2017-08-09
Participant Flow
13 were enrolled and 3 participants withdrew prior to randomization
Participant milestones
| Measure |
Anakinra
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
Baseline characteristics by cohort
| Measure |
Anakinra
n=5 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.4 years
n=99 Participants
|
74 years
n=107 Participants
|
73 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 72 hours following surgeryPopulation: IL-1ra measurements were invalid due to cross-reaction with the assay platform.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 72 hours following surgeryAnalgesic 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
Outcome measures
| Measure |
Anakinra
n=5 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
PCA/IV - Dilaudid (mg)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
PCA/IV - Fentanyl (mcg)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
PCA/IV - Morphine
|
4 Participants
|
4 Participants
|
|
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
PO - Oxycontin(tab)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
PO - Percocet(tab)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
PO - Acetaminophen(tab)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 72 hours following surgeryPopulation: Participants with available data were analyzed.
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)
Outcome measures
| Measure |
Anakinra
n=4 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Post-operative Pain Intensity
Pain Intensity at Rest Day One
|
2.25 units on a Visual Analog scale
Interval 0.0 to 3.0
|
2.8 units on a Visual Analog scale
Interval 0.0 to 7.0
|
|
Post-operative Pain Intensity
Pain Intensity on Stimulation Day One
|
7 units on a Visual Analog scale
Interval 5.0 to 10.0
|
6.4 units on a Visual Analog scale
Interval 3.0 to 10.0
|
|
Post-operative Pain Intensity
Pain Intensity at Rest Day Two
|
2.25 units on a Visual Analog scale
Interval 0.0 to 3.0
|
3.6 units on a Visual Analog scale
Interval 0.0 to 7.0
|
|
Post-operative Pain Intensity
Pain Intensity on Stimulation Day Two
|
3.3 units on a Visual Analog scale
Interval 0.0 to 6.0
|
6.2 units on a Visual Analog scale
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 72 hours following surgery plus 3 weeks follow-upEvaluation 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.
Outcome measures
| Measure |
Anakinra
n=5 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 72 hours following surgery plus 3 weeks follow-upEvaluation 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.
Outcome measures
| Measure |
Anakinra
n=5 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Count of Participants With Venous Thrombosis After Surgery During Hospitalization
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 72 hours following surgery plus 3 weeks follow-upEvaluation 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.
Outcome measures
| Measure |
Anakinra
n=5 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Assess Rates of Wound Dehiscence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 5 days maximum (admittance to discharge)Total length of hospital stay for patients enrolled in the study.
Outcome measures
| Measure |
Anakinra
n=5 Participants
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Anakinra: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
|
Saline Injection
n=5 Participants
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.
Normal Saline: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
|
|---|---|---|
|
Total Length of Hospital Stay
|
75.06 hours
Standard Deviation 17.37
|
87.76 hours
Standard Deviation 13.8
|
Adverse Events
Anakinra
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place