Back to resultsthe Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Transversus Abdominis Plane block
Sponsored by
About this trial
This is an interventional prevention trial for Colon Cancer focused on measuring minimal laparotomy, TAP block, morphine consumption, post-operative analgesia
Eligibility Criteria
Inclusion Criteria:
- Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger
Exclusion Criteria:
- increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
- a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
Sites / Locations
- department of anesthesia, Kaohsiung medical university memorial hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
morphine consumption
Arm Description
Outcomes
Primary Outcome Measures
amount of post-operative morphine consumption
Secondary Outcome Measures
evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale
Full Information
NCT ID
NCT01418391
First Posted
August 16, 2011
Last Updated
August 16, 2011
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01418391
Brief Title
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Official Title
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It had been reported the effect of post-operative pain control in minor abdominal surgery, such as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.
Detailed Description
outcome measures:
Hemodynamic parameters (mean artery pressure, heart rate): recorded at time points of before induction of general anesthesia (baseline), after tracheal intubation immediately, after surgery started 1, 2, 3, 4, 5, 10, 15, 20, 25, and 30 min; then recorded them every 10 mins.
Post-operative morphine consumption: recorded morphine consumption at the time intervals of post-operative 0~6 h, 6~12 h, 12~24 h, 24~36 h, and 36~48 h ,respectively. The total amount of morphine consumption was also counted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
minimal laparotomy, TAP block, morphine consumption, post-operative analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
morphine consumption
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane block
Other Intervention Name(s)
TAP block
Intervention Description
TAP BLOCK:
dosage form: 0.5% bupivacaine 75mg with 2% xylocaine 300 mg mixed dosage: total 30 ml frequency: single shot duration: 12~18 hours upon to the regional anesthetics choose
Primary Outcome Measure Information:
Title
amount of post-operative morphine consumption
Time Frame
post-operative 48 hours
Secondary Outcome Measure Information:
Title
evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale
Time Frame
post-operative 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger
Exclusion Criteria:
increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Te Hsu, VS
Phone
+886-7-3121101
Ext
7033
Email
hdhsu1228@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Te Hsu, VS
Organizational Affiliation
Department of anesthesia, Kaoshiung medical university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of anesthesia, Kaohsiung medical university memorial hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Te Hsu, VS
Phone
+886-7-312-1101
Ext
7033
Email
hdhsu1228@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hung-Te Hsu, VS
12. IPD Sharing Statement
Learn more about this trial
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
We'll reach out to this number within 24 hrs