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Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
local anesthetic
Dexamethasone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective surgery
  • ASA 1, II, AND III

Exclusion Criteria:

  • Patient refusal
  • Infection at the entry site
  • BMI > 3

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

dexmethasone group

control group

Arm Description

8 mg dexamethasone will be added to local anaesthetics

isobaric bupivacaine will be given on each side

Outcomes

Primary Outcome Measures

postoperative analgesia duration
time of first analgesic requirement is the time of end of block analgesia

Secondary Outcome Measures

postoperative complications related to the block
occurrence of complications secondary to the block well be recorded

Full Information

First Posted
July 9, 2018
Last Updated
March 9, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03731468
Brief Title
Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery
Official Title
Effect of Dexmethasone Addition to Bupivacaine in Bilateral Intermediate Cervical Block in Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia
Detailed Description
80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmethasone group
Arm Type
Active Comparator
Arm Description
8 mg dexamethasone will be added to local anaesthetics
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
isobaric bupivacaine will be given on each side
Intervention Type
Drug
Intervention Name(s)
local anesthetic
Intervention Description
ultrasound guided superficial cervical block in thyroid surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery
Primary Outcome Measure Information:
Title
postoperative analgesia duration
Description
time of first analgesic requirement is the time of end of block analgesia
Time Frame
24 hour postoperative
Secondary Outcome Measure Information:
Title
postoperative complications related to the block
Description
occurrence of complications secondary to the block well be recorded
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective surgery ASA 1, II, AND III Exclusion Criteria: Patient refusal Infection at the entry site BMI > 3
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery

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