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Trial record 11 of 440 for:    Taipei Medical University Hospital

Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery (TAP)

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ClinicalTrials.gov Identifier: NCT02029755
Recruitment Status : Completed
First Posted : January 8, 2014
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
hsiao chien tsai, Taipei Medical University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Postoperative Pain
Interventions Procedure: transversus abdominis plane block
Procedure: local infiltration
Procedure: Patient controlled analgesia
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAP Block Local Infiltration PCA Only
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 36 36 36
Completed 36 36 36
Not Completed 0 0 0
Arm/Group Title TAP Block Local Infiltration PCA Only Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 36 36 36 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 36 participants 108 participants
40.17  (7.28) 39.69  (5.38) 42.69  (6.93) 40.85  (6.65)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 36 participants 36 participants 36 participants 108 participants
36 36 36 108
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 36 participants 108 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
36
 100.0%
36
 100.0%
36
 100.0%
108
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 36 participants 36 participants 36 participants 108 participants
36 36 36 108
1.Primary Outcome
Title Pain Score (NRS: Numerical Rating Scale)
Hide Description

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.

Time Frame postoperative 24 hour dynamic
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAP Block Local Infiltration PCA Only
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 36 36 36
Mean (Standard Error)
Unit of Measure: units on a scale
4.50  (1.98) 4.81  (1.77) 4.17  (1.25)
2.Primary Outcome
Title Opioid Consumption
Hide Description opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
Time Frame postoperative 48 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAP Block Local Infiltration PCA Only
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 36 36 36
Mean (Standard Deviation)
Unit of Measure: mg
27.69  (19.20) 28.33  (15.89) 21.53  (16.99)
3.Secondary Outcome
Title Sedation Scale
Hide Description [Not Specified]
Time Frame postoperative 1, 6, 24, 48 hour
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Nausea and Vomiting Categorical Score
Hide Description [Not Specified]
Time Frame postoperative 1, 6, 24, 48 hour
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rescue Analgesic Use
Hide Description [Not Specified]
Time Frame postoperative 1, 6, 12, 24, 36, 48 hour
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Rescue Antiemetics Use
Hide Description [Not Specified]
Time Frame postoperative 1, 6, 12, 24, 36, 48 hour
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to the First Request of Analgesics
Time Frame an expected average of 5 days
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Pruritus
Hide Description [Not Specified]
Time Frame postoperative 1, 6, 24, 48 hour
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Quality of Recovery 40
Hide Description [Not Specified]
Time Frame postoperative 48 hour
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Heart Rate Variability
Hide Description [Not Specified]
Time Frame preoperative, postoperative 1 hour and 1 day
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Time to Flatus
Time Frame an expected average of 5 days
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Length of Hospital Stay
Time Frame an expected average of 5 days
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Number of Participants With Intervention-related Complication
Time Frame an expected average of 5 days
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAP Block Local Infiltration PCA Only
Hide Arm/Group Description

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

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

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

All-Cause Mortality
TAP Block Local Infiltration PCA Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAP Block Local Infiltration PCA Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAP Block Local Infiltration PCA Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/36 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Hsiao-Chien Tsai
Organization: Taipei medical university hospital
Phone: +886-2-27372181 ext 8310
Responsible Party: hsiao chien tsai, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT02029755     History of Changes
Other Study ID Numbers: 201309028
First Submitted: January 5, 2014
First Posted: January 8, 2014
Results First Submitted: November 21, 2014
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015