Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain

NCT ID: NCT03277599

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-05

Study Completion Date

2017-07-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Management Nerve Block Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective,randomized,single blind
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Grup Y

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

Group Type ACTIVE_COMPARATOR

IV patient-controlled analgesia (PCA) tramadol

Intervention Type 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.

ultrasound guided superficial cervical plexus block

Intervention Type DRUG

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

Grup B

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

Group Type ACTIVE_COMPARATOR

IV patient-controlled analgesia (PCA) tramadol

Intervention Type 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.

ultrasound guided Great Auricular nerve block

Intervention Type DRUG

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

Interventions

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IV patient-controlled analgesia (PCA) tramadol

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.

Intervention Type DRUG

ultrasound guided superficial cervical plexus block

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

Intervention Type DRUG

ultrasound guided Great Auricular nerve block

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

Intervention Type DRUG

Other Intervention Names

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Tramadol superficial cervical plexus block Great Auricular nerve block

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Korgün Ökmen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Korgün Ökmen, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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2011-KAEK-25 2016/21-02

Identifier Type: -

Identifier Source: org_study_id

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