Rotator Cuff Tear
Conditions
Keywords
morphine, nalbuphine, arthroscopic rotator cuff repair, ultrasound guided interscalene block
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.
Interventions
DRUGMorphine
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
DRUGNalbuphine
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
DRUGBupivacaine 0.5%
10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
DRUGLidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the total number of analgesic requests | 72 hours postoperative followup | 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
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 72 hours followup | \- 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 | 72 hours followup | — |
| duration of analgesia | 72 hours followup | duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS. |
| number of vomiting attacks | 72 hours followup | 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 | 72 hours followup | Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe). |
| sedation score | 72 hours followup | 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). |
Countries
Egypt
Contacts
Primary ContactShimaa A Husien, Msc
Outcome results
None listed