NCT00964600

Brief Summary

The patients planned to go under elective cesarean delivery under general anesthesia are randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic requirements are recorded. It's supposed that both are significantly reduced in patients undergoing TAP block.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 18, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

August 20, 2009

Last Update Submit

November 17, 2010

Conditions

Postoperative Pain

Keywords

transversus abdominis blockpostoperative paincesarean

Outcome Measures

Primary Outcomes (1)

  • Pain intensity after cesarean section

    one year

Secondary Outcomes (1)

  • Analgesic prescribed measurement

    one year

Study Arms (2)

TAP blockade

EXPERIMENTAL

bilateral TAP blockade at the end of cesarean delivery

Procedure: TAP blockade

No TAP

NO INTERVENTION

These patients would have usual analgesic drugs after cesarean

Interventions

TAP blockadePROCEDURE

15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm

TAP blockade

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective cesarean delivery
  • Term pregnancies
  • General anesthesia
  • Pfannenstiel incision

You may not qualify if:

  • No history of sensitivity to prescribed analgesic (Bupivacaine or related substances)
  • No preeclampsia
  • No history of psychologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharati hospital

Tehran, Tehran Province, 14114, Iran

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Laleh Eslamian, MD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 25, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

November 18, 2010

Record last verified: 2010-11

Locations

IR(1)