Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain

NCT03277599 | Completed

• 1 other identifier: 2011-KAEK-25 2016/21-02
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Analgesia following tympanomastoid surgery is critical for the prevention of postoperative . There are very few regional anesthesia methods used to achieve this goal.

Conditions

Pain Management; Nerve Block; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Scale

  Visual Analog Pain Scale was used for pain

  Postoperative 24 hours

Secondary Outcomes (3)

• tramadol consumption

  Postoperative 24 hour

• side effect profile

  Postoperative 24 hour

• additional analgesic use

  Postoperative 24 hour

Study Arms (2)

Grup Y

ACTIVE COMPARATOR

ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol

Drug: IV patient-controlled analgesia (PCA) tramadol; Drug: ultrasound guided superficial cervical plexus block

Grup B

ACTIVE COMPARATOR

ultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol

Drug: IV patient-controlled analgesia (PCA) tramadol; Drug: ultrasound guided Great Auricular nerve block

Interventions

IV patient-controlled analgesia (PCA) tramadol DRUG

Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 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.

Also known as: Tramadol

Grup B; Grup Y

ultrasound guided superficial cervical plexus block DRUG

ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine

Also known as: superficial cervical plexus block

Grup Y

ultrasound guided Great Auricular nerve block DRUG

ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol

Also known as: Great Auricular nerve block

Grup B

Eligibility Criteria

• Age: 20 Years - 70 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 and underwent Tympanomastoid surgery.

You may not qualify if:

• Previous history of opioid use preoperatively,
• Allergy to local anesthetics,
• The presence of any systemic infection,
• Uncontrolled arterial hypertension,
• Uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Tramadol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Korgün Ökmen, M.D

  University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita

  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: Principal Investigator

Model Details: prospective,randomized,single blind

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: September 11, 2017
• Study Start: July 5, 2016
• Primary Completion: December 5, 2016
• Study Completion: July 7, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03