Superior Trunk Block Applied for Upper Arm Surgery

Investigation of the Effectiveness of Superior Trunk Block Applied for Upper Arm Surgery Operation Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: superior trunk block; Drug: intravenous patient-controlled analgesia

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were in the American Society of Anesthesiologists (ASA) I-III class
• Underwent 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: superior trunk block; 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.	Procedure: superior trunk block; Local anesthetic injection will be applied to the superior trunk of the brachial plexus accompanied by ultrasonography.; Drug: intravenous patient-controlled analgesia; Analgesics will be given using a patient-controlled analgesia device.
Active Comparator: tramadol; 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.	Drug: intravenous patient-controlled analgesia; Analgesics will be given using a patient-controlled analgesia device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tramadol consumption amount	tramadol consumption amount with patient-controlled analgesia device	Postoperative 24 hours
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.	Postoperative 24 hours
postoperative complications	shortness of breath, hiccups, hoarseness	Postoperative 24 hours
Horner syndrome	Horner syndrome is a rare condition classically presenting with partial ptosis (drooping or falling of upper eyelid), miosis (constricted pupil), and facial anhidrosis (loss of sweating) due to a disruption in the sympathetic nerve supply	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Korgün Ökmen, Assoc. PhD., Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2022/06-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No