Trial Outcomes & Findings for Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain (NCT NCT02527083)
NCT ID: NCT02527083
Last Updated: 2025-12-31
Results Overview
Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
1 month, 3 months, 6 months, 12 months
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
BALANCED INHALATIONAL
Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Sevoflurane
Remifentanil
|
TIVA-K
Total intravenous anesthetic with ketamine
Propofol
Ketamine
|
TIVA-R
Total intravenous anesthetic with remifentanil
Propofol
Remifentanil
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
Baseline characteristics by cohort
| Measure |
BALANCED INHALATIONAL
n=6 Participants
Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Sevoflurane
Remifentanil
|
TIVA-K
n=2 Participants
Total intravenous anesthetic with ketamine
Propofol
Ketamine
|
TIVA-R
n=2 Participants
Total intravenous anesthetic with remifentanil
Propofol
Remifentanil
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=1000 Participants
|
68 years
n=1986 Participants
|
73 years
n=2008 Participants
|
67.5 years
n=4994 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
10 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
10 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
0 Participants
n=4994 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=1000 Participants
|
2 participants
n=1986 Participants
|
2 participants
n=2008 Participants
|
10 participants
n=4994 Participants
|
|
Pain level in PACU
|
6 Pain score (0-10)
STANDARD_DEVIATION 2.68 • n=1000 Participants
|
6.5 Pain score (0-10)
STANDARD_DEVIATION 4.95 • n=1986 Participants
|
6.5 Pain score (0-10)
STANDARD_DEVIATION 3.54 • n=2008 Participants
|
6.2 Pain score (0-10)
STANDARD_DEVIATION 2.86 • n=4994 Participants
|
PRIMARY outcome
Timeframe: 1 month, 3 months, 6 months, 12 monthsPopulation: Only 10 subjects were enrolled, and the numbers represented a typical distribution of Inhalational to TIVA use. Because of the low subject numbers, statistical differences between the techniques were not sought.
Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.
Outcome measures
| Measure |
BALANCED INHALATIONAL
n=6 Participants
Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Sevoflurane
Remifentanil
|
TIVA-K
n=2 Participants
Total intravenous anesthetic with ketamine
Propofol
Ketamine
|
TIVA-R
n=2 Participants
Total intravenous anesthetic with remifentanil
Propofol
Remifentanil
|
|---|---|---|---|
|
Pain Score, Chronic
1 Month
|
1.7 score on a scale
Standard Deviation 2.7
|
1.5 score on a scale
Standard Deviation 2.1
|
0 score on a scale
Standard Deviation 0
|
|
Pain Score, Chronic
3 Months
|
.8 score on a scale
Standard Deviation 1.6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Pain Score, Chronic
6 Months
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Pain Score, Chronic
12 Months
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 dayAcute Pain on Day 1, as measured by the Pain Quality Assessment Scale (PQAS). The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores means worse pain.
Outcome measures
| Measure |
BALANCED INHALATIONAL
n=6 Participants
Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Sevoflurane
Remifentanil
|
TIVA-K
n=2 Participants
Total intravenous anesthetic with ketamine
Propofol
Ketamine
|
TIVA-R
n=2 Participants
Total intravenous anesthetic with remifentanil
Propofol
Remifentanil
|
|---|---|---|---|
|
Pain Score, Acute
|
4.6 score on a scale
Standard Deviation 3.5
|
9.0 score on a scale
Standard Deviation 0
|
3.0 score on a scale
Standard Deviation 1.4
|
Adverse Events
TIVA-R
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BALANCED INHALATIONAL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TIVA-K
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