Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
- Registration Number
- NCT03034382
- Lead Sponsor
- Assiut University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
- ASA physical status I - Ш.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Morphine Morphine 5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. Nalbuphine Nalbuphine 5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000. Bupivacaine 0.5% Bupivacaine 0.5% 10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block. Morphine and Nalbuphine Morphine 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 Morphine and Nalbuphine 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method duration of analgesia 72 hours followup duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
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 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).
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).
Trial Locations
- Locations (1)
Assiut University Hospitals
🇪🇬Assiut, Egypt