Clinical trial NCT04194385: Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery
Official title: Comparison of Perioperative Analgesic Efficacy of Ultrasonography Guided Upper Trunk Block and Costoclavicular Infraclavicular Brachial Plexus Block in Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Phrenic Nerve Paralysis
Keywords: bupivacaine
costoclavicular block
upper trunk block
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper trunk block (UTB) and costoclavicular brachial plexus (CCBPB) block. This randomized controlled trial will compare ultrasound-guided UTB and CCBPB in patients undergoing arthroscopic shoulder surgery.

The main outcome is pain intensity score at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rating scale (NRS) from 0 to 10. The investigators research hypothesis is that UTB and CCBPB will result in equivalent postoperative analgesia at 30 minutes in the PACU.


Eligibility criteria: Inclusion Criteria:

1. American Association of Anesthesiologists (ASA) physical status I - III
2. BMI 20 to 35 kg / m2
3. Patients scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria:

1. Patients who refuse to participate in the study,
2. Pre-existing (obstructive or restrictive) lung disease,
3. Coagulopathy,
4. Sepsis,
5. Hepatic or renal insufficiency,
6. Pregnancy
7. Allergy to local anesthetic drugs,
8. Chronic pain condition requiring opioid intake at home,
9. Surgery in the neck or infraclavicular region
10. BMI above 40.
11. History of psychiatric diseases needing treatment.
12. Failure of nerve block performed in the preoperative block room
13. Substance abuse history

Primary outcomes:
measure: Detection of diaphragmatic paralysis by ultrasonography
timeFrame: 30 minutes after block application
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hour after surgery
measure: Pain intensity score
timeFrame: 30 minutes, 1,3, 6, 12, 24 hour after surgery
measure: Block perform time
timeFrame: The time from the needle enters the skin until the block is completed
measure: Block onset time
timeFrame: Until sensory and motor block occurs
measure: Intraoperative fentanyl requirement
timeFrame: From the beginning to the end of the operation
measure: Patient satisfaction: NRS
timeFrame: 24 hour after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Serdar Yeşiltaş, Instructor
role: PRINCIPAL_INVESTIGATOR
References: