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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Drug: Morphine
* Drug: Nalbuphine
* Drug: Bupivacaine 0.5%
* Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br>5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. | Drug: Morphine<br>* 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<br>* Other names: morphine sulphate;Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000<br>* 10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block<br>* Other names: lidocaine HCL and Adrenaline;|
| Experimental: Nalbuphine<br>5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. | Drug: Nalbuphine<br>* 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<br>* Other names: nubain;Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000<br>* 10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block<br>* Other names: lidocaine HCL and Adrenaline;|
| Experimental: Morphine and Nalbuphine<br>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<br>* 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<br>* Other names: morphine sulphate;Drug: Nalbuphine<br>* 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<br>* Other names: nubain;Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000<br>* 10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block<br>* Other names: lidocaine HCL and Adrenaline;|
| Placebo Comparator: Bupivacaine 0.5%<br>10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block. | Drug: Bupivacaine 0.5%<br>* 10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block<br>* Other names: Marcaine HCL;Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000<br>* 10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block<br>* Other names: lidocaine HCL and Adrenaline;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morphine, nalbuphine, arthroscopic rotator cuff repair, ultrasound guided interscalene block