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

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03786562
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.8
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Obesity	Drug: Intrathecal Morphine; Drug: Intrathecal Morphine + Intravenous Nalbuphine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.
• Actual Study Start Date: Mar 8, 2019
• Anticipated Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo group	Drug: Intrathecal Morphine; Group 1
Active Comparator: Nalbuphine group	Drug: Intrathecal Morphine + Intravenous Nalbuphine; Group 2

Outcome Measures

Primary Outcome Measures

1. postoperative nausea and vomiting [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 .

Secondary Outcome Measures

1. postoperative pain and puririts. [24 hours]

   Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman A. Ismail, Clinical Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT03786562
• Other Study ID Numbers: 01003060501
• First Posted: Dec 26, 2018
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity, Abdominal; Morphine; Nalbuphine

Study Results

No Results Posted as of Mar 16, 2020