Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

Not Applicable

Recruiting

• Conditions: Phrenic Nerve Paralysis; Shoulder Pain
• Interventions: Procedure: Upper trunk block; Procedure: Costoclavicular block; Procedure: Diaphragmatic function assessment; Procedure: Cervical plexus blockade

• Registration Number: NCT04194385
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2020-05-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper trunk block	Upper trunk block	In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Upper trunk block	Diaphragmatic function assessment	In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Upper trunk block	Cervical plexus blockade	In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Costoclavicular brachial plexus block	Diaphragmatic function assessment	In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Costoclavicular brachial plexus block	Cervical plexus blockade	In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Costoclavicular brachial plexus block	Costoclavicular block	In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

Primary Outcome Measures

Name	Time	Method
Detection of diaphragmatic paralysis by ultrasonography	30 minutes after block application	Ipsilateral diaphragmatic excursion 30 minutes after block completion

Secondary Outcome Measures

Name	Time	Method
Block perform time	The time from the needle enters the skin until the block is completed	Block application time will be recorded
Postoperative opioid consumption	24 hour after surgery	Total amount of tramadol consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Block onset time	Until sensory and motor block occurs	Block onset time will be evaluated and recorded.
Pain intensity score	30 minutes, 1,3, 6, 12, 24 hour after surgery	Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be )
Patient satisfaction: NRS	24 hour after surgery	Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Intraoperative fentanyl requirement	From the beginning to the end of the operation	During the operation, 0.5 μg/kg fentanyl was administered to the patient in case of a 20% increase in the mean blood pressure and heart rate compared to the baseline values

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 Istanbul, Fatih, Turkey