- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03786562
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Mohamed Bakri, Prof
- Phone Number: +20882413201
- Email: mhbakri@gmail.com
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01003060501
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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