Systemic Nalbuphine Versus Intravenous Regional Anesthesia
Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03150732
Collaborator
(none)
106
2
14
Study Details
Study Description
Brief Summary
Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groupsTwo groups
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia
Anticipated Study Start Date
:
Apr 10, 2022
Anticipated Primary Completion Date
:
Dec 10, 2022
Anticipated Study Completion Date
:
Jun 10, 2023
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- Duration of postoperative Analgesia [Postoperative 24 hours]
minutes
Secondary Outcome Measures
- Diclofenac analgesic consumption [Postoperative 24 hours]
mg
- Cortisol level [Preoperative and at 4 hours after skin incision]
Level of cortisone in blood (nmol/L)
- Severity of postoperative Pain [Postoperative 24 hours]
Visual Analogue Scale (VAS)
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mohamed Bakri,
Professor of anesthesia & ICU,
Assiut University
ClinicalTrials.gov Identifier:
NCT03150732
Other Study ID Numbers:
- 000087273
First Posted:
May 12, 2017
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
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
Additional relevant MeSH terms: