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Superior Trunk Block Applied for Upper Arm and Shoulder Surgery

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
superior trunk block
intravenous patient-controlled analgesia
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class
  • Underwent Shoulder surgery and upper arm surgery

Exclusion Criteria:

  • Previous local anesthetic allergy,
  • Having a bleeding diathesis disorder,
  • Mental disorder,
  • Allergic to the drugs used,
  • Patients who did not consent to participate in the study,
  • Presence of infection in the block area,
  • Patients with a body mass index above 30

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    superior trunk block

    tramadol

    Arm Description

    Ultrasound guided superior trunk block with 10 ml % 0.25 bupivacaine + 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

    400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale
    Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)

    Secondary Outcome Measures

    tramadol consumption amount
    tramadol consumption amount with patient-controlled analgesia device
    additional analgesic use amount
    The amount of paracetamol (intravenous, 1 g) or non-steroidal anti-inflammatory drug to be administered to patients with a Visuel analog scale above 5 after the operation.

    Full Information

    First Posted
    July 19, 2022
    Last Updated
    July 21, 2022
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05474014
    Brief Title
    Superior Trunk Block Applied for Upper Arm and Shoulder Surgery
    Official Title
    Investigation of the Effectiveness of Superior Trunk Block Applied for Upper Arm and Shoulder Surgery Operation Analgesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 20, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. Providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery. In this study aimed to investigate the effect of superior trunk block application on postoperative analgesic and motor functions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    superior trunk block
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound guided superior trunk block with 10 ml % 0.25 bupivacaine + 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
    Arm Title
    tramadol
    Arm Type
    Active Comparator
    Arm Description
    400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
    Intervention Type
    Procedure
    Intervention Name(s)
    superior trunk block
    Intervention Description
    Local anesthetic injection will be applied to the superior trunk of the brachial plexus accompanied by ultrasonography.
    Intervention Type
    Drug
    Intervention Name(s)
    intravenous patient-controlled analgesia
    Intervention Description
    Analgesics will be given using a patient-controlled analgesia device.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale
    Description
    Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
    Time Frame
    Postoperative 24 hours
    Secondary Outcome Measure Information:
    Title
    tramadol consumption amount
    Description
    tramadol consumption amount with patient-controlled analgesia device
    Time Frame
    Postoperative 24 hours
    Title
    additional analgesic use amount
    Description
    The amount of paracetamol (intravenous, 1 g) or non-steroidal anti-inflammatory drug to be administered to patients with a Visuel analog scale above 5 after the operation.
    Time Frame
    Postoperative 24 hours

    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: Patients who were in the American Society of Anesthesiologists (ASA) I-III class Underwent Shoulder surgery and upper arm surgery Exclusion Criteria: Previous local anesthetic allergy, Having a bleeding diathesis disorder, Mental disorder, Allergic to the drugs used, Patients who did not consent to participate in the study, Presence of infection in the block area, Patients with a body mass index above 30
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Korgün Ökmen, Assoc. PhD.
    Phone
    +905057081021
    Email
    korgunokmen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Korgün Ökmen, Assoc. PhD.
    Organizational Affiliation
    Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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