Back to resultsMorphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
Primary Purpose
Rotator Cuff Tear
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Morphine
Nalbuphine
Bupivacaine 0.5%
Lidocaine Hydrochloride 1% and epinephrine 1:400,000
Sponsored by
About this trial
This is an interventional prevention trial for Rotator Cuff Tear focused on measuring morphine, nalbuphine, arthroscopic rotator cuff repair, ultrasound guided interscalene block
Eligibility 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.
Sites / Locations
- Assiut University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Morphine
Nalbuphine
Morphine and Nalbuphine
Bupivacaine 0.5%
Arm Description
5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
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
10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.
Outcomes
Primary Outcome Measures
the total number of analgesic requests
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
duration of analgesia
duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
patient satisfaction
- 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).
The first time to ask for analgesics
sedation score
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).
number of vomiting attacks
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.
itching
Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03034382
Brief Title
Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
Official Title
Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
morphine, nalbuphine, arthroscopic rotator cuff repair, ultrasound guided interscalene block
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
Experimental
Arm Description
5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
Arm Title
Nalbuphine
Arm Type
Experimental
Arm Description
5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
Arm Title
Morphine and Nalbuphine
Arm Type
Experimental
Arm Description
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
Arm Title
Bupivacaine 0.5%
Arm Type
Placebo Comparator
Arm Description
10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
morphine sulphate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Other Intervention Name(s)
nubain
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5%
Other Intervention Name(s)
Marcaine HCL
Intervention Description
10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride 1% and epinephrine 1:400,000
Other Intervention Name(s)
lidocaine HCL and Adrenaline
Intervention Description
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Primary Outcome Measure Information:
Title
the total number of analgesic requests
Description
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.
Time Frame
72 hours postoperative followup
Secondary Outcome Measure Information:
Title
duration of analgesia
Description
duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
Time Frame
72 hours followup
Title
patient satisfaction
Description
- 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).
Time Frame
72 hours followup
Title
The first time to ask for analgesics
Time Frame
72 hours followup
Title
sedation score
Description
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).
Time Frame
72 hours followup
Title
number of vomiting attacks
Description
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.
Time Frame
72 hours followup
Title
itching
Description
Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).
Time Frame
72 hours followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa A Husien, Msc
Phone
01002953253
Ext
002
Email
shimo.9feb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud A Aly, Prof
Organizational Affiliation
Assiut University Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kawser H Mohammed, Prof
Organizational Affiliation
Assiut University Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayman A Mamdouh, Ass Prof
Organizational Affiliation
Assiut University Hospitals
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman A Mamdouh, AssProf
Phone
01066066001
Ext
002
Email
aymanosman2000@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
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