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
  Purpose

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 Intervention
Colon Cancer
Procedure: Transversus Abdominis Plane block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • amount of post-operative morphine consumption [ Time Frame: post-operative 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 16, 2011
Last Updated: August 16, 2011
Health Authority: Taiwan: Institutional Review Board

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014