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

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ClinicalTrials.gov Identifier: NCT01418391
Recruitment Status : Unknown
Verified May 2011 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Transversus Abdominis Plane block Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Study Start Date : June 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: morphine consumption 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




Primary Outcome Measures :
  1. amount of post-operative morphine consumption [ Time Frame: post-operative 48 hours ]

Secondary Outcome Measures :
  1. evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale [ Time Frame: post-operative 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418391


Contacts
Contact: Hung-Te Hsu, VS +886-7-3121101 ext 7033 hdhsu1228@hotmail.com

Locations
Taiwan
department of anesthesia, Kaohsiung medical university memorial hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Hung-Te Hsu, VS    +886-7-312-1101 ext 7033    hdhsu1228@hotmail.com   
Principal Investigator: Hung-Te Hsu, VS         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Hung-Te Hsu, VS Department of anesthesia, Kaoshiung medical university hospital

Responsible Party: Hung-Te Hsu/ Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01418391     History of Changes
Other Study ID Numbers: KMUH-IRB-990400
KMUH-IRB-990400 ( Other Identifier: KaohsiungMU )
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: May 2011

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
minimal laparotomy
TAP block
morphine consumption
post-operative analgesia