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
  • Drug: Systemic nalbuphine
  • Drug: Local nalbuphine
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

  1. Duration of postoperative Analgesia [Postoperative 24 hours]

    minutes

Secondary Outcome Measures

  1. Diclofenac analgesic consumption [Postoperative 24 hours]

    mg

  2. Cortisol level [Preoperative and at 4 hours after skin incision]

    Level of cortisone in blood (nmol/L)

  3. 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:

Study Results

No Results Posted as of Feb 28, 2022