The Effect of Intravenous Nalbuphine on PONV With Intrath... | NCT03786562

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

NCT03786562

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 16, 2020Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Abdominal Obesity

Interventions

Intrathecal Morphine
Intrathecal Morphine + Intravenous Nalbuphine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2019Actual

Primary Completion Date

Mar 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 20, 2018

First Posted Date

Dec 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2020

Last Update Posted Date

Mar 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo group	Placebo Comparator		Drug: Intrathecal Morphine
Nalbuphine group	Active Comparator		Drug: Intrathecal Morphine + Intravenous Nalbuphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrathecal Morphine	Drug	Group 1	Placebo group
Intrathecal Morphine + Intravenous Nalbuphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 .	24 hours

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female undergoing abdominoplasty

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Bakri, Prof	Contact	+20882413201		mhbakri@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital	Recruiting	Asyut			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D056128	Obesity, Abdominal

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided