NCT03786562

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

December 19, 2018

Last Update Submit

March 13, 2020

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • postoperative pain and puririts.

    24 hours

Study Arms (2)

Placebo group

PLACEBO COMPARATOR
Drug: Intrathecal Morphine

Nalbuphine group

ACTIVE COMPARATOR
Drug: Intrathecal Morphine + Intravenous Nalbuphine

Interventions

Intrathecal MorphineDRUG

Group 1

Placebo group
Intrathecal Morphine + Intravenous NalbuphineDRUG

Group 2

Nalbuphine group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale undergoing abdominoplasty
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing abdominoplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) class I and II.

You may not qualify if:

  • allergy to local anesthetics
  • bleeding diatheses
  • local infection or sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Bakri, Prof

CONTACT

+20882413201mhbakri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 26, 2018

Study Start

March 8, 2019

Primary Completion

March 1, 2020

Study Completion

September 1, 2020

Last Updated

March 16, 2020

Record last verified: 2019-03

Locations

EG(1)