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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Experimental | 5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine 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. |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shimaa A Husien, Msc | Contact | 01002953253 | 002 | shimo.9feb@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud A Aly, Prof | Assiut University Hospitals | Study Chair |
| Kawser H Mohammed, Prof | Assiut University Hospitals | Study Chair |
| Ayman A Mamdouh, Ass Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospitals | Recruiting | Asyut | 71515 | Egypt |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D009266 | Nalbuphine |
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
| Assiut University Hospitals |
| Study Director |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |