Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection; Bupivacaine HCl 0.025 % in 10+10 ML Injection; Bupivacaine HCl 0.025 % in 5+5 ML Injection; Isotonic solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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 10 ml +10 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 5 ml +5 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
Other intervention name(s): Marcaine; Marcaine; Marcaine; serum physiologic
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: suprascapular nerve block; axillary nerve block; Regional Anesthesia; Analgesic consumption; Postoperative analgesia; Numeric rating scale