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

March 13, 2020 updated by: Eman A. Ismail, Assiut University

The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.

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

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Assiut, Egypt
        • Recruiting
        • Assiut university Hospital
        • Contact:
          • Eman Ismail, A professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo group
Group 1
ACTIVE_COMPARATOR: Nalbuphine group
Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .

24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain and puririts.
Time Frame: 24 hours
Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 8, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (ACTUAL)

December 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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