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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516268
First Posted: January 24, 2012
Last Update Posted: March 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laleh Eslamian, Tehran University of Medical Sciences
  Purpose
Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.

Condition Intervention Phase
Pain Drug: Sufentanyl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Laleh Eslamian, Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Narcotic Dosage [ Time Frame: 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.


Secondary Outcome Measures:
  • Pain [ Time Frame: 24h ]

Enrollment: 50
Study Start Date: January 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516268


Locations
Iran, Islamic Republic of
Shariati hospital, TUMS
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Laleh Eslamian, MD TUMS, Tehran University of Medical Sciences
  More Information

Responsible Party: Laleh Eslamian, Associated Prof.MD, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01516268     History of Changes
Other Study ID Numbers: 886
First Submitted: January 19, 2012
First Posted: January 24, 2012
Results First Submitted: February 19, 2013
Results First Posted: March 27, 2013
Last Update Posted: March 27, 2013
Last Verified: February 2013

Keywords provided by Laleh Eslamian, Tehran University of Medical Sciences:
Cesarean Delivery
TAP block
sufentanyl
Narcotic dosages

Additional relevant MeSH terms:
Bupivacaine
Sufentanil
Narcotics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General