The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery (TAP)

February 19, 2013 updated by: Laleh Eslamian, Tehran University of Medical Sciences

the Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane (TAP) Block Under the Guide of Ultrasound to Reduce the Narcotic Dosage, Side Effects and Pain in the First 24 Hours After Cesarean Delivery

Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female 18 to 40 Years
  • class ASA 1 and 2
  • candidates for elective cesarean section

Exclusion Criteria:

  • renal failure
  • liver failure
  • cardiac disorder
  • coagulopathy
  • hepatomegaly
  • splenomegaly
  • drug sensitivity and abuse
  • morbid obesity
  • smoking
  • history of post operative nausea and vomiting
  • motion sickness
  • local hypoesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sufentanyl group
IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
Drug: Sufentanyl

As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.

As comparator 1cc normal saline is added to bupivacain in control group for Tap block.
Placebo Comparator: Control group
In control group we add 1cc salin to 20cc bupivacain in TAP block
Drug: Sufentanyl

As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.

As comparator 1cc normal saline is added to bupivacain in control group for Tap block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Dosage
Time Frame: 24 h
24 h
Narcotic Dosage
Time Frame: over 24 hours after surgery
The total dosage of morphin consumed by the patients in sufentanil or control group.
over 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 24h
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Laleh Eslamian, MD, TUMS, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 886

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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