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The Perioperative Analgesic Efficiency of Bilateral Superficial Cervical Plexus Block in Patients With Thyroidectomy

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Completed
CT.gov ID
NCT02680353
Collaborator
(none)
47
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the postoperative analgesic efficiency of bilateral superficial plexus block, patients are divided into two groups. Study group received bilateral superficial plexus block, where control had none. Visual analog scale, opioid consumption and presence of nausea-vomiting are recorded.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bilateral superficial cervical plexus block
 N/A

Detailed Description

Bilateral superficial cervical plexus block has successfully been demonstrated to provide an efficient analgesia in patients with thyroidectomy, parathyroidectomy, carotis end-arterectomy. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of bilateral superficial cervical plexus block in patients with total thyroidectomy. After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire. Patients are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, bilateral superficial cervical plexus block is performed to study group and no intervention to control group. At the end of the operation all patients received paracetamol 1 gr intravenous. In postoperative period, visual analog scale values, opioid consumption, presence of nausea-vomiting, anti-emetic usage or any other complications are recorded.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Perioperative Analgesic Efficiency of Bilateral Superficial Cervical Plexus Block in Patients With Thyroidectomy
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Study group

Patients received bilateral superficial cervical plexus block before operation

Procedure: Bilateral superficial cervical plexus block
A kind of anesthetic nerve block type performed to block the nerve function temporarily by administrating local anesthetics through the trajectory of the nerve.
No Intervention: Control group

Patients received no intervention before operation

Outcome Measures

Primary Outcome Measures

  1. Visual analog scale [one time in postoperative period for one year]

Secondary Outcome Measures

  1. Presence of nausea-vomiting [In postoperative period for one year]

  2. Mean arterial pressure [In both intraoperative and postoperative period for one year]

  3. Heart rate [In both intraoperative and postoperative period for one year]

  4. Antiemetic usage [postoperative period for one year]

  5. respiratory rate [postoperative period for one year]

  6. opioid consumption [During postoperative period for one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Over 18 years of age

  • Planned to undergo thyroidectomy

  • An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

  • Severe cardiovascular disease

  • Psychiatric diseases

  • Difficult intubation

  • Rejected to participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziosmanpasa University Tokat Turkey 60200

Sponsors and Collaborators

  • Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Hakan Tapar, Assist.Prof, Gaziosmanpasa University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hakan Tapar, Assist.Prof., Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier:
NCT02680353
Other Study ID Numbers:
  • 15-KAEK-055
First Posted:
Feb 11, 2016
Last Update Posted:
Apr 19, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Apr 19, 2017