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Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries

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ClinicalTrials.gov Identifier: NCT03034382
Recruitment Status : Unknown
Verified May 2017 by Shimaa Abbas Hassan, Assiut University.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Shimaa Abbas Hassan, Assiut University

Study Description
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Brief Summary:
the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Drug: Morphine Drug: Nalbuphine Drug: Bupivacaine 0.5% Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : June 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Morphine
5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
 Drug: Morphine
5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Name: morphine sulphate

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Name: lidocaine HCL and Adrenaline
Experimental: Nalbuphine
5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
 Drug: Nalbuphine
5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Name: nubain

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Name: lidocaine HCL and Adrenaline
Experimental: Morphine and Nalbuphine

5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.

combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block

 Drug: Morphine
5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Name: morphine sulphate

Drug: Nalbuphine
5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Name: nubain

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Name: lidocaine HCL and Adrenaline
Placebo Comparator: Bupivacaine 0.5%
10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.
 Drug: Bupivacaine 0.5%
10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
Other Name: Marcaine HCL

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Name: lidocaine HCL and Adrenaline


Outcome Measures
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Primary Outcome Measures :
  1. the total number of analgesic requests [ Time Frame: 72 hours postoperative followup ]
    the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.


Secondary Outcome Measures :
  1. duration of analgesia [ Time Frame: 72 hours followup ]
    duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.

  2. patient satisfaction [ Time Frame: 72 hours followup ]
    - The patient satisfaction score. Patients were also asked to rate their satisfaction with the analgesia on a scale of 0-10 (0 for total dissatisfaction to 10 for total satisfaction).

  3. The first time to ask for analgesics [ Time Frame: 72 hours followup ]
  4. sedation score [ Time Frame: 72 hours followup ]
    recorded every 4 hours; ranging from alert, drowsy, sleeping but responsive to verbal commands up to unarousable (we consider sedation score 3 or more as clinically significant sedation that mandate close patient observation every hour).

  5. number of vomiting attacks [ Time Frame: 72 hours followup ]
    recorded every 4 hours. A vomiting attack was defined by events of vomiting that occurred in a rapid sequence (<1 minute between events). If vomiting was separated by more than 1 minute; they will be considered to be separate attacks. Retching (the same as vomiting but without expulsion of gastric contents) was considered as vomiting. If the patient experienced vomiting; ondansetron 4 mg IV was given.

  6. itching [ Time Frame: 72 hours followup ]
    Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
  • ASA physical status I - Ш.

Exclusion Criteria:

  • Infection at the site of injection.
  • Coagulopathy or other bleeding diathesis.
  • Known allergy to drugs in the study
  • Preexisting neurologic deficits in the area to be blocked.
  • Inability to communicate with the investigator and the hospital staff.
  • History of chronic opioid use.
  • Morbid obesity BMI>40.
Contacts and Locations
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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): NCT03034382


Contacts
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Contact: Shimaa A Husien, Msc 01002953253 ext 002 shimo.9feb@gmail.com

Locations
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Egypt
Assiut University Hospitals Recruiting
Assiut, Egypt, 71515
Contact: Ayman A Mamdouh, AssProf    01066066001 ext 002    aymanosman2000@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mahmoud A Aly, Prof Assiut University Hospitals
Study Chair: Kawser H Mohammed, Prof Assiut University Hospitals
Study Director: Ayman A Mamdouh, Ass Prof Assiut University Hospitals
More Information
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Responsible Party: Shimaa Abbas Hassan, Primary investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03034382    
Other Study ID Numbers: SH1
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shimaa Abbas Hassan, Assiut University:
morphine
nalbuphine
arthroscopic rotator cuff repair
ultrasound guided interscalene block
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Lidocaine
Epinephrine
Morphine
Nalbuphine
Bupivacaine
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents