NCT01418391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 17, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

August 16, 2011

Last Update Submit

August 16, 2011

Conditions

Keywords

minimal laparotomyTAP blockmorphine consumptionpost-operative analgesia

Outcome Measures

Primary Outcomes (1)

  • amount of post-operative morphine consumption

    post-operative 48 hours

Secondary Outcomes (1)

  • evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale

    post-operative 48 hours

Study Arms (1)

morphine consumption

EXPERIMENTAL
Procedure: Transversus Abdominis Plane block

Interventions

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

Also known as: TAP block
morphine consumption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of anesthesia, Kaohsiung medical university memorial hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Hung-Te Hsu, VS

    Department of anesthesia, Kaoshiung medical university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 17, 2011

Record last verified: 2011-05

Locations