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

Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Drug: Morphine; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000; Drug: Nalbuphine; Drug: Bupivacaine 0.5%

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University Hospitals
    • Contact: Ayman A Mamdouh, AssProf; Phone Number: 002 01066066001; Email: aymanosman2000@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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: 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 Names: lidocaine HCL and Adrenaline; 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 Names: nubain
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 Names: 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 Names: lidocaine HCL and Adrenaline; 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 Names: nubain
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: 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 Names: lidocaine HCL and Adrenaline; 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 Names: Marcaine HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of analgesia	duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.	72 hours followup
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).	72 hours followup
The first time to ask for analgesics		72 hours followup
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).	72 hours followup
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.	72 hours followup
itching	Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).	72 hours followup

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: morphine; arthroscopic rotator cuff repair; nalbuphine; ultrasound guided interscalene block
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Bupivacaine; Morphine; Epinephrine; Nalbuphine
• Other Study ID Numbers: SH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided