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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03786562
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : March 16, 2020
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.
Actual Study Start Date : March 8, 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).

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT03786562

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Contact: Mohamed Bakri, Prof +20882413201

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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 Identifier: NCT03786562    
Other Study ID Numbers: 01003060501
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: March 16, 2020
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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Obesity, Abdominal
Nutrition Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents