Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277599
• Other study ID #: 2011-KAEK-25 2016/21-02
• Status: Completed
• Phase: N/A
• First received: July 17, 2017
• Last updated: March 19, 2018
• Start date: July 5, 2016
• Est. completion date: July 7, 2017

Study information

• Verified date: March 2018
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 7, 2017
• Est. primary completion date: December 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Block
• Pain Management
• Ultrasound

Intervention

Drug:
• 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.
• ultrasound guided superficial cervical plexus block
ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine
• ultrasound guided Great Auricular nerve block
ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale	Visual Analog Pain Scale was used for pain	Postoperative 24 hours
Secondary	tramadol consumption	tramadol consumption	Postoperative 24 hour
Secondary	side effect profile	side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)	Postoperative 24 hour
Secondary	additional analgesic use	additional analgesic use	Postoperative 24 hour