Back to resultsNalbuphine as an Adjuvant to Intravenous Regional Anesthesia
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine
Lidocaine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- adult patients
- American Society of Anesthesiologists (ASA) physical status I-II
- age between 20 and 50 years old
- scheduled for elective unilateral short hand surgery
Exclusion Criteria:
- allergy to study medications
- body mass index > 35 kg/m2
- patients with sickle cell disease or Reynaud disease
- patient refusal
Sites / Locations
- Assiut university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Nalbuphine
Control group
Arm Description
53 patients received intravenous regional lidocaine plus Nalbuphine
53 patients received intravenous regional lidocaine
Outcomes
Primary Outcome Measures
Tourniquet and postoperative pain measured by visual analogue scale
Secondary Outcome Measures
Cortisol level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02678585
Brief Title
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
Official Title
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
5. Study Description
Brief Summary
The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalbuphine
Arm Type
Active Comparator
Arm Description
53 patients received intravenous regional lidocaine plus Nalbuphine
Arm Title
Control group
Arm Type
Other
Arm Description
53 patients received intravenous regional lidocaine
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
53 patients received intravenous regional lidocaine plus nalbuphine
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
53 patients received intravenous regional lidocaine
Primary Outcome Measure Information:
Title
Tourniquet and postoperative pain measured by visual analogue scale
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Cortisol level
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients
American Society of Anesthesiologists (ASA) physical status I-II
age between 20 and 50 years old
scheduled for elective unilateral short hand surgery
Exclusion Criteria:
allergy to study medications
body mass index > 35 kg/m2
patients with sickle cell disease or Reynaud disease
patient refusal
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
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