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

August 18, 2011
August 2, 2012
August 2011
March 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01423292 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Laparoscopic Colecctomy
  • 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)
  • Drug: Placebo
    placebo
  • Active Comparator: an odd numbered patients
    TAP block with local anesthetics
    Interventions:
    • Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block
    • Drug: bupivacaine
  • Placebo Comparator: an even numbered patients
    TAP block without local anesthetics
    Interventions:
    • Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01423292
NCCCTS-11-557
Not Provided
Ji Won Park, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Not Provided
National Cancer Center, Korea
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP