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Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01423292
First Posted: August 25, 2011
Last Update Posted: August 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea
  Purpose
The purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.

Condition Intervention Phase
Laparoscopic Colecctomy Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block Drug: bupivacaine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Ji Won Park, National Cancer Center, Korea:

Primary Outcome Measures:
  • pain score during cough [ Time Frame: 24hr after TAP block ]
    pain score during cough at 24 hours after TAP block (using visual analog scale)


Secondary Outcome Measures:
  • pain score during bed rest and ambulation at ward, dosage of used opioid, nausea score, sedation score, days of hospitalization, start day of diet, reinsertion rate of urinary catheter, satisfaction measurement of pain control, life of quality [ Time Frame: 24hr, 48hr, 72hr after TAP block ]

Enrollment: 56
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: an odd numbered patients
TAP block with local anesthetics
Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Drug: bupivacaine
0.25 bupivacaine 30ml (15ml on each side)
Placebo Comparator: an even numbered patients
TAP block without local anesthetics
Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Drug: Placebo
placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 20~80
  • undergoing laparoscopic colectomy

Exclusion Criteria:

  • allergic history to local anesthesitcs
  • tolerance to opioid
  • cannot use IV-PCA
  • previous abdominal surgery
  • intestinal obstruction
  • emergency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423292


Locations
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

Responsible Party: Ji Won Park, Center for Colorectal Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01423292     History of Changes
Other Study ID Numbers: NCCCTS-11-557
First Submitted: August 18, 2011
First Posted: August 25, 2011
Last Update Posted: August 6, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents