- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06626191
Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ISBPB
Comparison of the Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Interscalene Brachial Plexus Block in Shoulder Arthroscopy
Shoulder arthroscopy is one of the common surgical procedures performed today. After shoulder surgery, providing adequate analgesia is necessary for both the comfort of the patient and the ability to perform the necessary post-operative rehabilitation exercises early and regularly.
Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.
In this study; it was aimed to compare the analgesic effectiveness of interscalene brachial plexus block and serratus posterior superior intercostal plane block, with each other and with the control group in the postoperative period in patients who underwent shoulder arthroscopy.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey (Türkiye), 06000
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Exclusion Criteria:
- Patients under 18 and over 80 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interscalene brachial plexus block
After the patients are monitored and in the supine position, after appropriate field sterilization, interscalene brachial plexus block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacaine) under ultrasound guidance.
In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.
|
Interscalene brachial plexus block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacaine) under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. |
|
Active Comparator: Group without peripheral nerve block
After the patients are monitored, they will be operated under general anesthesia without peripheral nerve block and intraoperative intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.
|
In the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
|
|
Active Comparator: Serratus posterior superior intercostal plane block
After the patients are monitored and in the sitting position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance.
In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.
|
Patients will undergo serratus posterior superior intercostal plane block using 30 ml of local anesthetic solution (0.25% bupivacaine) under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Scores
Time Frame: 24 hours after surgery
|
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Tramadol Consumption
Time Frame: 24 hours after surgery
|
Tramadol consumption for 24 hours will be recorded
|
24 hours after surgery
|
|
Intraoperative remifentanil consumption Intraoperative opioid consumption
Time Frame: Intraoperative period
|
Remifentanil consumption for intraoperative period will be recorded
|
Intraoperative period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK1-2024-0073
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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