Trial Outcomes & Findings for Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery (NCT NCT02029755)
NCT ID: NCT02029755
Last Updated: 2015-06-08
Results Overview
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
postoperative 24 hour dynamic
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
TAP Block
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
Local Infiltration
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
PCA Only
postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery
Baseline characteristics by cohort
| Measure |
TAP Block
n=36 Participants
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
Local Infiltration
n=36 Participants
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
PCA Only
n=36 Participants
postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.17 years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
39.69 years
STANDARD_DEVIATION 5.38 • n=7 Participants
|
42.69 years
STANDARD_DEVIATION 6.93 • n=5 Participants
|
40.85 years
STANDARD_DEVIATION 6.65 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
36 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
108 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
36 participants
n=5 Participants
|
108 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: postoperative 24 hour dynamicpain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Outcome measures
| Measure |
TAP Block
n=36 Participants
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
Local Infiltration
n=36 Participants
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
PCA Only
n=36 Participants
postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
|---|---|---|---|
|
Pain Score (NRS: Numerical Rating Scale)
|
4.50 units on a scale
Standard Error 1.98
|
4.81 units on a scale
Standard Error 1.77
|
4.17 units on a scale
Standard Error 1.25
|
PRIMARY outcome
Timeframe: postoperative 48 houropioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
Outcome measures
| Measure |
TAP Block
n=36 Participants
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
Local Infiltration
n=36 Participants
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
PCA Only
n=36 Participants
postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine
|
|---|---|---|---|
|
Opioid Consumption
|
27.69 mg
Standard Deviation 19.20
|
28.33 mg
Standard Deviation 15.89
|
21.53 mg
Standard Deviation 16.99
|
SECONDARY outcome
Timeframe: postoperative 1, 6, 24, 48 hourOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postoperative 1, 6, 24, 48 hourOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postoperative 1, 6, 12, 24, 36, 48 hourOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postoperative 1, 6, 12, 24, 36, 48 hourOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: an expected average of 5 daysparticipants will be followed for the duration of hospital stay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postoperative 1, 6, 24, 48 hourOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postoperative 48 hourOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: preoperative, postoperative 1 hour and 1 dayOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: an expected average of 5 daysparticipants will be followed for the duration of hospital stay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: an expected average of 5 daysparticipants will be followed for the duration of hospital stay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: an expected average of 5 daysparticipants will be followed for the duration of hospital stay
Outcome measures
Outcome data not reported
Adverse Events
TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Infiltration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCA Only
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
Dr. Hsiao-Chien Tsai
Taipei medical university hospital
Phone: +886-2-27372181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place