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

Not Applicable

• Conditions: Colon Cancer
• Interventions: Procedure: Transversus Abdominis Plane block

• Registration Number: NCT01418391
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2011-05
• Study Start: 2011-06
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-16
• Last Update Submitted: 2011-08-16
• Study First Posted: 2011-08-17
• Last Update Posted: 2011-08-17
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
morphine consumption	Transversus Abdominis Plane block	-

Primary Outcome Measures

Name	Time	Method
amount of post-operative morphine consumption	post-operative 48 hours

Secondary Outcome Measures

Name	Time	Method
evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale	post-operative 48 hours

Trial Locations

Locations (1)

department of anesthesia, Kaohsiung medical university memorial hospital; 🇨🇳 Kaohsiung, Taiwan