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:

Information provided by (Responsible Party):

Laleh Eslamian, Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01516268

First received: January 19, 2012

Last updated: February 19, 2013

Last verified: February 2013

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Sufentanil citrate

U.S. FDA Resources

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

Primary Outcome Measures:

Narcotic Dosage [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
Narcotic Dosage [ Time Frame: over 24 hours after surgery ] [ Designated as safety issue: Yes ]
The total dosage of morphin consumed by the patients in sufentanil or control group.

Secondary Outcome Measures:

Pain [ Time Frame: 24h ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Laleh Eslamian, Associated Prof.MD, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01516268 History of Changes
Other Study ID Numbers:	886
Study First Received:	January 19, 2012
Results First Received:	February 19, 2013
Last Updated:	February 19, 2013
Health Authority:	Health ministry of Iran:Iran

Keywords provided by 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
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 23, 2013

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