the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01418391
First received: August 16, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

August 16, 2011
August 16, 2011
June 2011
June 2012   (final data collection date for primary outcome measure)
amount of post-operative morphine consumption [ Time Frame: post-operative 48 hours ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale [ Time Frame: post-operative 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Colon Cancer
Procedure: Transversus Abdominis Plane block

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

Other Name: TAP block
Experimental: morphine consumption
Intervention: Procedure: Transversus Abdominis Plane block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Hung-Te Hsu, VS +886-7-3121101 ext 7033 hdhsu1228@hotmail.com
Taiwan
 
NCT01418391
KMUH-IRB-990400, KMUH-IRB-990400
Yes
Hung-Te Hsu/ Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: Hung-Te Hsu, VS Department of anesthesia, Kaoshiung medical university hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP