NCT01548027

Brief Summary

The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

March 5, 2012

Last Update Submit

July 30, 2014

Conditions

Child

Keywords

TAP blockpostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • opioids consumption

    total opioids consumption in first 24 hours postoperatively

    24 hours

Secondary Outcomes (1)

  • Time to first analgesic

    24 hr

Study Arms (3)

No intervention

EXPERIMENTAL

no injection of local anesthetic agents

Other: No intervention

Local infiltration group

EXPERIMENTAL

patients would have 0.5 ml/kg of 0.25% bupivacaine if age \< 6 months or 1 ml/kg if age \> 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.

Procedure: Local infiltration group

TAP block group

EXPERIMENTAL

Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age \< 6 months or 1 ml/kg if age \> 6 months

Procedure: TAP block

Interventions

Local infiltration groupPROCEDURE

patients would have 0.5 ml/kg of 0.25% bupivacaine if age \< 6 months or 1 ml/kg if age \> 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.

Also known as: local anesthetic infiltration
Local infiltration group
TAP blockPROCEDURE

Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age \< 6 months or 1 ml/kg if age \> 6 months

Also known as: surgical transversus abdominis plane block
TAP block group
No interventionOTHER

No intervention

No intervention

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age \< 15 year
  • ASA I-III
  • Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
  • Elective surgery

You may not qualify if:

  • Allergic to Lidocaine or bupivacaine
  • Delayed development
  • Major abdominal surgery within 2 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Study Officials

  • Saowaphak Lapmahapaisan, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

TH(1)