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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03786562
Other study ID # 01003060501
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2019
Est. completion date September 2020

Study information

Verified date March 2019
Source Assiut University
Contact Mohamed Bakri, Prof
Phone +20882413201
Email mhbakri@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Intrathecal Morphine
Group 1
Intrathecal Morphine + Intravenous Nalbuphine
Group 2

Locations

Country Name City State
Egypt Assiut University Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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