Trial Outcomes & Findings for Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy (NCT NCT01074229)
NCT ID: NCT01074229
Last Updated: 2014-05-08
Results Overview
QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
1 day
Results posted on
2014-05-08
Participant Flow
Participant milestones
| Measure |
Placebo
Group B (control group) will receive sterile normal saline.
|
20 cc of 0.5% Ropivacaine
Group A (study group) 20 cc of 0.5% ropivacaine
|
20 cc of 0.25% Ropivacaine
Active Comparator 2. 20 cc of 0.25% ropivacaine
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Group B (control group) will receive sterile normal saline.
|
20 cc of 0.5% Ropivacaine
Group A (study group) 20 cc of 0.5% ropivacaine
|
20 cc of 0.25% Ropivacaine
Active Comparator 2. 20 cc of 0.25% ropivacaine
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Change to open surgical procedure
|
1
|
3
|
4
|
Baseline Characteristics
Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Group B (control group) will receive sterile normal saline.
|
Study Drug
n=25 Participants
Group A (study group) 20 cc of 0.5% ropivacaine
|
20 cc of 0.25% Ropivacaine
n=25 Participants
Active Comparator 2. 20 cc of 0.25% ropivacaine
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
45.4 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
46.76 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
46.55 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
25 participants
n=206 Participants
|
75 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 dayQoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.
Outcome measures
| Measure |
PLACEBO
n=23 Participants
Group B (control group) will receive sterile normal saline.
|
20 cc of 0.5% Ropivacaine
n=22 Participants
STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
|
20 cc of 0.25% Ropivacaine
n=21 Participants
Active Comparator 2. 20 cc of 0.25% ropivacaine
|
|---|---|---|---|
|
QoR40 on the Day After Surgery
|
152 units on a scale
Inter-Quartile Range 22.8 • Interval 136.0 to 167.0
|
180 units on a scale
Inter-Quartile Range 12.16 • Interval 169.0 to 190.0
|
180 units on a scale
Inter-Quartile Range 15.3 • Interval 161.0 to 184.0
|
SECONDARY outcome
Timeframe: 1 dayTotal 24 total morphine consumption post operative.
Outcome measures
| Measure |
PLACEBO
n=23 Participants
Group B (control group) will receive sterile normal saline.
|
20 cc of 0.5% Ropivacaine
n=22 Participants
STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
|
20 cc of 0.25% Ropivacaine
n=21 Participants
Active Comparator 2. 20 cc of 0.25% ropivacaine
|
|---|---|---|---|
|
24 Total Morphine Consumption
|
22.75 miligrams of morphine
Standard Deviation 10.75
|
12.5 miligrams of morphine
Standard Deviation 9.84
|
17.5 miligrams of morphine
Standard Deviation 13.07
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20 cc of 0.25% Ropivacaine
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