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Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

Primary Purpose

Shoulder Pain, Phrenic Nerve Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper trunk block
Costoclavicular block
Diaphragmatic function assessment
Cervical plexus blockade
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring bupivacaine, costoclavicular block, upper trunk block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakıf UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Upper trunk block

Costoclavicular brachial plexus block

Arm Description

In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

Outcomes

Primary Outcome Measures

Detection of diaphragmatic paralysis by ultrasonography
Ipsilateral diaphragmatic excursion 30 minutes after block completion

Secondary Outcome Measures

Postoperative opioid consumption
Total amount of tramadol consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Pain intensity score
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be )
Block perform time
Block application time will be recorded
Block onset time
Block onset time will be evaluated and recorded.
Intraoperative fentanyl requirement
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
Patient satisfaction: NRS
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)

Full Information

First Posted
December 9, 2019
Last Updated
April 4, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04194385
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Phrenic Nerve Paralysis
Keywords
bupivacaine, costoclavicular block, upper trunk block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upper trunk block
Arm Type
Active Comparator
Arm Description
In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Arm Title
Costoclavicular brachial plexus block
Arm Type
Active Comparator
Arm Description
In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Intervention Type
Procedure
Intervention Name(s)
Upper trunk block
Other Intervention Name(s)
Upper trunk brachial plexus block
Intervention Description
Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .
Intervention Type
Procedure
Intervention Name(s)
Costoclavicular block
Other Intervention Name(s)
Costoclavicular brachial plexus block
Intervention Description
Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Intervention Type
Procedure
Intervention Name(s)
Diaphragmatic function assessment
Other Intervention Name(s)
Detection of diaphragmatic paralysis with ultrasound guidance
Intervention Description
Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Cervical plexus blockade
Other Intervention Name(s)
Superficial cervical plexus blockade
Intervention Description
Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.
Primary Outcome Measure Information:
Title
Detection of diaphragmatic paralysis by ultrasonography
Description
Ipsilateral diaphragmatic excursion 30 minutes after block completion
Time Frame
30 minutes after block application
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Total amount of tramadol consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Time Frame
24 hour after surgery
Title
Pain intensity score
Description
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be )
Time Frame
30 minutes, 1,3, 6, 12, 24 hour after surgery
Title
Block perform time
Description
Block application time will be recorded
Time Frame
The time from the needle enters the skin until the block is completed
Title
Block onset time
Description
Block onset time will be evaluated and recorded.
Time Frame
Until sensory and motor block occurs
Title
Intraoperative fentanyl requirement
Description
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
Time Frame
From the beginning to the end of the operation
Title
Patient satisfaction: NRS
Description
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Time Frame
24 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Association of Anesthesiologists (ASA) physical status I - III BMI 20 to 35 kg / m2 Patients scheduled for elective arthroscopic shoulder surgery Exclusion Criteria: Patients who refuse to participate in the study, Pre-existing (obstructive or restrictive) lung disease, Coagulopathy, Sepsis, Hepatic or renal insufficiency, Pregnancy Allergy to local anesthetic drugs, Chronic pain condition requiring opioid intake at home, Surgery in the neck or infraclavicular region BMI above 40. History of psychiatric diseases needing treatment. Failure of nerve block performed in the preoperative block room Substance abuse history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Yeşiltaş, Instructor
Phone
+90 542 363 26 30
Email
syesiltas@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Yeşiltaş, Instructor
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar Yeşiltaş, Assist.Prof

12. IPD Sharing Statement

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Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

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