Back to resultsThe Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.
Primary Purpose
Abdominal Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intrathecal Morphine
Intrathecal Morphine + Intravenous Nalbuphine
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Obesity
Eligibility 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
Sites / Locations
- Assiut University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo group
Nalbuphine group
Arm Description
Outcomes
Primary Outcome Measures
postoperative nausea and vomiting
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
postoperative pain and puririts.
Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03786562
Brief Title
The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.
Official Title
The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
Nalbuphine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine
Intervention Description
Group 1
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine + Intravenous Nalbuphine
Intervention Description
Group 2
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Description
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 .
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
postoperative pain and puririts.
Description
Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female undergoing abdominoplasty
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Bakri, Prof
Phone
+20882413201
Email
mhbakri@gmail.com
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Ismail, A professor
12. IPD Sharing Statement
Learn more about this trial
The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.
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