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Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678585
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Bakri, Assiut University

Brief Summary:
The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Nalbuphine Drug: Lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nalbuphine
53 patients received intravenous regional lidocaine plus Nalbuphine
Drug: Nalbuphine
53 patients received intravenous regional lidocaine plus nalbuphine

Control group
53 patients received intravenous regional lidocaine
Drug: Lidocaine
53 patients received intravenous regional lidocaine




Primary Outcome Measures :
  1. Tourniquet and postoperative pain measured by visual analogue scale [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Cortisol level [ Time Frame: 4 hours ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678585


Locations
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Egypt
Assiut university hospital
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohamed Bakri, Associate professor, Assiut University
ClinicalTrials.gov Identifier: NCT02678585    
Other Study ID Numbers: 000087161
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Nalbuphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics