Pain, Postoperative
Conditions
Keywords
suprascapular nerve block, axillary nerve block, Regional Anesthesia, Analgesic consumption, Postoperative analgesia, Numeric rating scale
Brief summary
The research is designed as a single-center, prospective, randomized double-blind study. The patients undergoing shoulder arthroscopy surgery in Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will be excluded. Ultrasonography (USG) guided combined suprascapular and axillary block will be performed routinely for postoperative analgesia. After the block is performed, general anesthesia will be applied. The patients will be divided into 4 groups. Three different doses of local anesthetic will be given to patients (30 cc vs 20 cc vs 10 cc). Local anesthetic dose will be the same for suprascapular and axillary blocks. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patient will be observed for postoperative nausea and vomiting, first time to mobilization, length of hospital stay, analgesic consumption and satisfaction of surgeon and patient.
Detailed description
The investigators research was designed as a single-center, prospective, randomized double-blind study. After the approval of the Ethics Committee, the study will start and is aimed to be completed in 6 months. The patients consecutively undergoing shoulder arthroscopy surgery in Istanbul University Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study. Preoperative evaluation of the patients will include detailed history, demographic and clinical parameters including gender, age, indication for shoulder arthroscopy, creatinine, chronic disease history will be recorded. Patients will be taken to the operating room after premedication with 2 mg midazolam and 50 mg fentanyl. Patients will be monitored for rhythm, blood oxygen and pressure in the operating room. Ultrasonography (USG) guided suprascapular and axillary block will be performed. Suprascapular and axillary block will be done for postoperative analgesia. After the block is done, general anesthesia will be applied. In this study there will be four groups with the control group included. For the first group 15cc+15cc , for the second group 10cc+10cc for the third group 5cc+5cc of local anesthetic will be injected. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patients will be followed up for 48 hours postoperatively in routine practice. They will be observed for postoperative nausea and vomiting, first mobilisation time, lenght of hospital stay, analgesic consumption and surgent and patient satisfaction. Before the study, it was determined that at least 132 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, statistical analysis will be performed with Statistical Package for the Social Sciences (SPSS). The investigators study does not contain any modifications other than the investigators daily routine practices.
Interventions
DRUGBupivacaine HCl 0.025 % in 10+10 ML Injection
In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
DRUGBupivacaine HCl 0.025 % in 5+5 ML Injection
In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
DRUGBupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection
In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for total shoulder arthroscopy surgery * Patients with American Society of Anesthesiology (ASA) Class 1-3
Exclusion criteria
* Refusal of regional anesthesia * Infection on the local anesthetic application area * Patients with known coagulopathy * Known allergy against local anesthetics * Anatomical difficulties to perform supra scapular and axillary blocks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (0-10) pain scores for patients | 48 hours | The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'') |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid (mg) consumption | postoperative period up to 48th hours. | Opioid (mg) consumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time until postoperative first mobilization | Up to 48 hours | First mobilization time |
| Length of hospital stay | Through study completion, an average of 1 week | Hospitalization |
| Time of onset of narcotic analgesic need | postoperative period up to 48th hours. | (If VAS \> 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg. |
| Surgeon satisfaction | postoperative period up to 48th hours and postoperative in the first month | Satisfaction score; 0- very unsatisfied, 3- very satisfied |
| Patient satisfaction | postoperative period up to 48th hours and postoperative in the first month | Satisfaction score; 0- very unsatisfied, 3- very satisfied |
| Incidence of side effects | postoperative period up to 48th hour | Incidence of nausea and vomiting |
Countries
Turkey (Türkiye)
Outcome results
None listed