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The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.

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ClinicalTrials.gov Identifier: NCT03786562
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eman A. Ismail, Assiut University

Brief Summary:
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery.

Condition or disease Intervention/treatment Phase
Abdominal Obesity Drug: Intrathecal Morphine Drug: Intrathecal Morphine + Intravenous Nalbuphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo group Drug: Intrathecal Morphine
Group 1

Active Comparator: Nalbuphine group Drug: Intrathecal Morphine + Intravenous Nalbuphine
Group 2




Primary Outcome Measures :
  1. postoperative nausea and vomiting [ Time Frame: 24 hours ]

    A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 10)

    by postoperative nausea and vomiting scale which range (o no nasuea to 10 sever vomating).

    A verbal descriptive scale (VDS) was used to assess the severity of PONV .



Secondary Outcome Measures :
  1. postoperative pain and puririts. [ Time Frame: 24 hours ]
    Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female undergoing abdominoplasty
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing abdominoplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) class I and II.

Exclusion Criteria:

  • allergy to local anesthetics
  • bleeding diatheses
  • local infection or sepsis

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): NCT03786562


Contacts
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Contact: Mohamed Bakri, Prof +20882413201 mhbakri@gmail.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt
Contact: Eman Ismail, A professor         
Sponsors and Collaborators
Assiut University

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Responsible Party: Eman A. Ismail, Clinical Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03786562     History of Changes
Other Study ID Numbers: 01003060501
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Obesity, Abdominal
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting
Obesity
Overnutrition
Nutrition Disorders
Morphine
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents