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

NCT ID: NCT01516268

Last Updated: 2013-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sufentanyl group

IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block

Group Type ACTIVE_COMPARATOR

Sufentanyl

Intervention Type DRUG

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.

Control group

In control group we add 1cc salin to 20cc bupivacain in TAP block

Group Type PLACEBO_COMPARATOR

Sufentanyl

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Laleh Eslamian

Associated Prof.MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laleh Eslamian, MD

Role: PRINCIPAL_INVESTIGATOR

TUMS, Tehran University of Medical Sciences

Locations

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Shariati hospital, TUMS

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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886

Identifier Type: -

Identifier Source: org_study_id

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