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

NCT03034382 | Unknown Phase 2

• 1 other identifier: SH1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

morphine; nalbuphine; arthroscopic rotator cuff repair; ultrasound guided interscalene block

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours postoperative followup

Secondary Outcomes (6)

• duration of analgesia

  72 hours followup

• patient satisfaction

  72 hours followup

• The first time to ask for analgesics

  72 hours followup

• sedation score

  72 hours followup

• number of vomiting attacks

  72 hours followup

Study Arms (4)

Morphine

EXPERIMENTAL

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

Drug: Morphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Nalbuphine

EXPERIMENTAL

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

Drug: Nalbuphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Morphine and Nalbuphine

EXPERIMENTAL

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; Drug: Nalbuphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Bupivacaine 0.5%

PLACEBO COMPARATOR

10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.

Drug: Bupivacaine 0.5%; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Interventions

Morphine DRUG

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

Also known as: morphine sulphate

Morphine; Morphine and Nalbuphine

Nalbuphine DRUG

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

Also known as: nubain

Morphine and Nalbuphine; Nalbuphine

Bupivacaine 0.5% DRUG

10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block

Also known as: Marcaine HCL

Bupivacaine 0.5%

Lidocaine Hydrochloride 1% and epinephrine 1:400,000 DRUG

10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block

Also known as: lidocaine HCL and Adrenaline

Bupivacaine 0.5%; Morphine; Morphine and Nalbuphine; Nalbuphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Morphine; Nalbuphine; Bupivacaine; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mahmoud A Aly, Prof

  Assiut University Hospitals

  STUDY CHAIR

• Kawser H Mohammed, Prof

  Assiut University Hospitals

  STUDY CHAIR

• Ayman A Mamdouh, Ass Prof

  Assiut University Hospitals

  STUDY DIRECTOR

Central Study Contacts

Shimaa A Husien, Msc

CONTACT

01002953253; shimo.9feb@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

EG (1)