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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01418391
• Other study ID #: KMUH-IRB-990400
• Secondary ID: KMUH-IRB-990400
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2011
• Last updated: August 16, 2011
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2011
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Hung-Te Hsu, VS
• Phone: +886-7-3121101
• Email: hdhsu1228[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colon Cancer

Intervention

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

Locations

Country	Name	City	State
Taiwan	department of anesthesia, Kaohsiung medical university memorial hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of post-operative morphine consumption		post-operative 48 hours	Yes
Secondary	evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale		post-operative 48 hours	Yes