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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01423292
First received: August 18, 2011
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • pain score during cough [ Time Frame: 24hr after TAP block ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 18, 2011
Last Updated: August 2, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013