NCT01423292

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

August 18, 2011

Last Update Submit

August 2, 2012

Conditions

Laparoscopic Colecctomy

Outcome Measures

Primary Outcomes (1)

  • pain score during cough

    pain score during cough at 24 hours after TAP block (using visual analog scale)

    24hr after TAP block

Secondary Outcomes (1)

  • 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

    24hr, 48hr, 72hr after TAP block

Study Arms (2)

an odd numbered patients

ACTIVE COMPARATOR

TAP block with local anesthetics

Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) BlockDrug: bupivacaine

an even numbered patients

PLACEBO COMPARATOR

TAP block without local anesthetics

Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) BlockDrug: Placebo

Interventions

Ultrasound Guided Transversus Abdominis Plane (TAP) BlockPROCEDURE

Ultrasound Guided Transversus Abdominis Plane (TAP) Block

an even numbered patientsan odd numbered patients
bupivacaineDRUG

0.25 bupivacaine 30ml (15ml on each side)

an odd numbered patients
PlaceboDRUG

placebo

an even numbered patients

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 20\~80
  • undergoing laparoscopic colectomy

You may not qualify if:

  • allergic history to local anesthesitcs
  • tolerance to opioid
  • cannot use IV-PCA
  • previous abdominal surgery
  • intestinal obstruction
  • emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Interventions

Dental OcclusionBupivacaine

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center for Colorectal Cancer

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 25, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

KR(1)