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

NCT ID: NCT01418391

Last Updated: 2011-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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morphine consumption

Group Type EXPERIMENTAL

Transversus Abdominis Plane block

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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TAP block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Principal Investigators

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Hung-Te Hsu, VS

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesia, Kaoshiung medical university hospital

Locations

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department of anesthesia, Kaohsiung medical university memorial hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Te Hsu, VS

Role: CONTACT

+886-7-3121101 ext. 7033

Facility Contacts

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Hung-Te Hsu, VS

Role: primary

+886-7-312-1101 ext. 7033

Other Identifiers

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KMUH-IRB-990400

Identifier Type: OTHER

Identifier Source: secondary_id

KMUH-IRB-990400

Identifier Type: -

Identifier Source: org_study_id

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