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
  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:


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
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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 July 24, 2014