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Completed

NCT Number: NCT04947007

Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection

Drug

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.

Other names: Marcaine

Bupivacaine HCl 0.025 % in 10+10 ML Injection

Drug

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.

Other names: Marcaine

Bupivacaine HCl 0.025 % in 5+5 ML Injection

Drug

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.

Other names: Marcaine

Isotonic Solution

Drug

In this group, US guided suprascapulary and axillary block will be performed with isotonic solution

Other names: serum physiologic

Primary outcomes

  1. Visual Analogue Scale (0-10) pain scores for patients

    Time frame: 48 hours

    The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')

Secondary outcomes

  1. Opioid (mg) consumption

    Time frame: postoperative period up to 48th hours.

    Opioid (mg) consumption

Other outcomes

  1. Time of onset of narcotic analgesic need

    Time frame: 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.

  2. Incidence of side effects

    Time frame: postoperative period up to 48th hour

    Incidence of nausea and vomiting

  3. Time until postoperative first mobilization

    Time frame: Up to 48 hours

    First mobilization time

  4. Length of hospital stay

    Time frame: Through study completion, an average of 1 week

    Hospitalization

  5. Patient satisfaction

    Time frame: postoperative period up to 48th hours and postoperative in the first month

    Satisfaction score; 0- very unsatisfied, 3- very satisfied

  6. Surgeon satisfaction

    Time frame: postoperative period up to 48th hours and postoperative in the first month

    Satisfaction score; 0- very unsatisfied, 3- very satisfied

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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