Trial Outcomes & Findings for Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery (NCT NCT01167907)
NCT ID: NCT01167907
Last Updated: 2018-08-31
Results Overview
The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved. "Verbal Pain Score" is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate "no pain" and is the best score Ten (10) is used to rate "the worst pain imaginable" and is the worst score
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
48 hours post nerve blockade
Results posted on
2018-08-31
Participant Flow
Participant milestones
| Measure |
0.2% Ropivacaine
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
0.2% Ropivacaine
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
saphenous catheter dislodged before comp
|
1
|
1
|
Baseline Characteristics
Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery
Baseline characteristics by cohort
| Measure |
0.2% Ropivacaine
n=17 Participants
Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.
0.2% ropivacaine: 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
|
Saline
n=15 Participants
Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.
saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours post nerve blockadeThe primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved. "Verbal Pain Score" is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate "no pain" and is the best score Ten (10) is used to rate "the worst pain imaginable" and is the worst score
Outcome measures
| Measure |
0.2% Ropivacaine
n=15 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Verbal Pain Scores
|
4.2 units on a scale
Standard Deviation 3.1
|
5.4 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 48 hours post nerve blockadeSecondary endpoints of reduction of opioid use will be evaluated. Outcome will be measured using 24h mg-equivalent oxycodone consumption. - (Units in mg/24h)
Outcome measures
| Measure |
0.2% Ropivacaine
n=15 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Opioid Use
|
35.1 mg per 24h
Standard Deviation 45.4
|
33.3 mg per 24h
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: 48 hours post nerve blockadeSecondary endpoints of reduction of nausea will be evaluated.
Outcome measures
| Measure |
0.2% Ropivacaine
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Nausea
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 48 hour post nerve blockadeSecondary endpoints of reduction of vomiting will be evaluated.
Outcome measures
| Measure |
0.2% Ropivacaine
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Vomiting
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hours post nerve blockadeSecondary endpoints of reduction of sleep disturbance (as number of awakenings) will be evaluated.
Outcome measures
| Measure |
0.2% Ropivacaine
n=15 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Sleep Disturbance
|
1.3 awakenings
Standard Deviation 1.9
|
1.6 awakenings
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 24 hours post nerve blockadeSecondary endpoints of reduction of quadriceps strength will be evaluated. To determine the effect of saphenous block on quadriceps function, patients will have knee extension muscle strength using a Hoggan Health microFET 2 MT Digital Handheld Dynamometer. Knee Extension: Measuring knee extension was performed with the digital dynamometer placed on the anterior surface of the lower leg proximal to the ankle.
Outcome measures
| Measure |
0.2% Ropivacaine
n=15 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
Saline
n=14 Participants
Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
|
|---|---|---|
|
Reduction of Quadriceps Strength
|
48.1 pounds
Standard Deviation 22.7
|
37.3 pounds
Standard Deviation 17.6
|
Adverse Events
0.2% Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
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