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OpenTrials
Completed

NCT Number: NCT03277599

Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain

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

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Key information

Conditions

Pain Management Agnosia Nerve Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Ultrasound

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In this study, it was aimed to investigate the effect of Ultrasound guided superficial cervical plexus block versus greater auricular nerve block for on postoperative tympanomastoid surgery analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Tympanomastoid surgery.

Exclusion criteria

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

Treatment and study plan

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.

Other names: Tramadol

ultrasound guided superficial cervical plexus block

Drug

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

Other names: superficial cervical plexus block

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

Other names: Great Auricular nerve block

Primary outcomes

  1. Visual Analog Pain Scale

    Time frame: Postoperative 24 hours

    Visual Analog Pain Scale was used for pain

Secondary outcomes

  1. tramadol consumption

    Time frame: Postoperative 24 hour

    tramadol consumption

  2. side effect profile

    Time frame: Postoperative 24 hour

    side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)

  3. additional analgesic use

    Time frame: Postoperative 24 hour

    additional analgesic use

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Ultrasound Guided Superficial Cervical Plexus Block Versus Greater Auricular Nerve Block for Tympanomastoid Surgery Pain

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 11, 2017
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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