NCT01516268

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 27, 2013

Completed
Last Updated

March 27, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

January 19, 2012

Results QC Date

February 19, 2013

Last Update Submit

February 19, 2013

Conditions

Pain

Keywords

Cesarean DeliveryTAP blocksufentanylNarcotic dosages

Outcome Measures

Primary Outcomes (2)

  • Narcotic Dosage

    24 h

  • Narcotic Dosage

    The total dosage of morphin consumed by the patients in sufentanil or control group.

    over 24 hours after surgery

Secondary Outcomes (1)

  • Pain

    24h

Study Arms (2)

Sufentanyl group

ACTIVE COMPARATOR

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

Drug: Sufentanyl

Control group

PLACEBO COMPARATOR

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

Drug: Sufentanyl

Interventions

SufentanylDRUG

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 groupSufentanyl group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati hospital, TUMS

Tehran, 14114, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Laleh Eslamian
Organization
Tehran University of Medical Sciences
leslamian@tums.ac.ir
0098218490

Study Officials

  • Laleh Eslamian, MD

    TUMS, Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Prof.MD

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 27, 2013

Results First Posted

March 27, 2013

Record last verified: 2013-02

Locations

IR(1)