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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

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

NCT ID

NCT03731468

First Posted

July 9, 2018

Last Updated

March 9, 2021

Sponsor

Assiut University

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

Studies a U.S. FDA-regulated Device Product

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

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

Learn more about this trial

Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery

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