Trial Outcomes & Findings for Postoperative Pain Control Following Renal Transplant (NCT NCT05044429)
NCT ID: NCT05044429
Last Updated: 2024-03-18
Results Overview
We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery
TERMINATED
PHASE4
31 participants
12 hours after surgery
2024-03-18
Participant Flow
Participant milestones
| Measure |
Intravenous Lidocaine
Intravenous Lidocaine: Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
|
Transversus Abdominis Plane (TAP) Block
Transversus abdominis plane (TAP) block: Subject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
|
Quadratus Lumborum (QL) Block
Quadratus Lumborum (QL) Block: Subject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
7
|
5
|
|
Overall Study
COMPLETED
|
19
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
trial was terminated before analysis of data
Baseline characteristics by cohort
| Measure |
Intravenous Lidocaine
n=19 Participants
Intravenous Lidocaine: Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
|
Transversus Abdominis Plane (TAP) Block
n=7 Participants
Transversus abdominis plane (TAP) block: Subject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
|
Quadratus Lumborum (QL) Block
n=5 Participants
Quadratus Lumborum (QL) Block: Subject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=19 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=19 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=31 Participants
|
|
Age, Continuous
|
49.1 years
n=19 Participants
|
49.8 years
n=7 Participants
|
52.2 years
n=5 Participants
|
49.8 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=19 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=19 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=19 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=19 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=19 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=19 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=19 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=19 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 36 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 12 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 24 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 36 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 36 hours after surgery
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 hours after surgeryPopulation: trial was terminated before the outcome measure data were collected
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 48 hours after surgery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately three daysPopulation: trial was terminated before the outcome measure data were collected
We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one weekPopulation: trial was terminated before the outcome measure data were collected
Occurs when the immune system identifies a grafted organ as foreign and attacks it
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: By time of hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
Temporary treatment for patients with acute renal failure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
Opioid toxicity requiring naloxone
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
Painful obstruction of the ileum or other part of the intestine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
Transplant time to discharge time
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
Number of days spent in the intensive care unit following transplant
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through hospital discharge, approximately four daysPopulation: trial was terminated before the outcome measure data were collected
Alive or dead at time of hospital discharge
Outcome measures
Outcome data not reported
Adverse Events
Intravenous Lidocaine
Transversus Abdominis Plane (TAP) Block
Quadratus Lumborum (QL) Block
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