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Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

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.
 
ClinicalTrials.gov Identifier: NCT00707824
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : July 8, 2008
Sponsor:
Information provided by:
Mahidol University

Study Description
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Brief Summary:
Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: nalbuphine Other: NSS Phase 4

Detailed Description:

182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally.

After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control.

Outcome measures :

Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus
Study Start Date : June 2000
Actual Primary Completion Date : December 2005
Actual Study Completion Date : February 2006

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
1= placebo
 Other: NSS
NSS
Other Name: nornal saline
Active Comparator: 2
2=nalbuphine 5 mg
 Drug: nalbuphine
nalbuphine 5 mg epidural
Other Name: nubain
Active Comparator: 3
3=nalbuphine 10 mg
 Drug: nalbuphine
nalbuphine 10 mg epidural
Other Name: nubaine


Outcome Measures
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Primary Outcome Measures :
  1. incidence and severity of pruritus [ Time Frame: 24 hr ]

Secondary Outcome Measures :
  1. visual analogue pain score [ Time Frame: 24 hr ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • full term parturient undergoing elective cesarean section
  • ASA 1-2

Exclusion Criteria:

  • drug or alcohol abuses
  • contraindication for regional anesthesia
  • received opioids within 12 hours
Contacts and Locations
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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): NCT00707824


Locations
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Thailand
Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Orawan Pongraweewan, MD Mahidol University
More Information
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Responsible Party: Assistant Professor Orawan Pongraweewan, Mahidol University
ClinicalTrials.gov Identifier: NCT00707824    
Other Study ID Numbers: 110/2000
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: February 2006
Keywords provided by Mahidol University:
pruritus
epidural morphine
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Nalbuphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents