Superior Trunk Block Applied for Upper Arm Surgery

NCT05474014 | Completed

• 1 other identifier: 2022/06-12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• tramadol consumption amount

  Postoperative 24 hours

• additional analgesic use amount

  Postoperative 24 hours

• postoperative complications

  Postoperative 24 hours

• Horner syndrome

  Postoperative 24 hours

Study Arms (2)

superior trunk block

ACTIVE COMPARATOR

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; Drug: intravenous patient-controlled analgesia

tramadol

ACTIVE COMPARATOR

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

Interventions

superior trunk block PROCEDURE

Local anesthetic injection will be applied to the superior trunk of the brachial plexus accompanied by ultrasonography.

superior trunk block

intravenous patient-controlled analgesia DRUG

Analgesics will be given using a patient-controlled analgesia device.

superior trunk block; tramadol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Korgün Ökmen, Assoc. PhD.

  Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Phd.M.D

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: July 20, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

TU (1)