Systemic Nalbuphine Versus Intravenous Regional Anesthesia

February 18, 2024 updated by: Mohamed Bakri, Assiut University

Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia

Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71526
        • Mohamed H Bakri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for elective unilateral hand surgery.

Exclusion Criteria:

  • Patient refusal.
  • Allergy to study medications
  • Body mass index > 35 kg/ m2
  • Patients with sickle cell or Reynaud diseases
  • Patients with a history of psychiatric illness or on chronic opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Systemic nalbuphine group
53 patients will receive nalbuphine systemically
Drug: Systemic nalbuphine
Patients will receive systemic nalbuphine 10 mg
Active Comparator: Local nalbuphine group
53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA)
Drug: Local nalbuphine
Patients will receive local nalbuphine 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative Analgesia
Time Frame: Postoperative 24 hours
minutes
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diclofenac analgesic consumption
Time Frame: Postoperative 24 hours
mg
Postoperative 24 hours
Cortisol level
Time Frame: Preoperative and at 4 hours after skin incision
Level of cortisone in blood (nmol/L)
Preoperative and at 4 hours after skin incision
Severity of postoperative Pain
Time Frame: Postoperative 24 hours
Visual Analogue Scale (VAS)
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Actual)

February 10, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000087273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Systemic nalbuphine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe