Intermediate Cervical Block Under Ultrasound for Thyroid Surgery: Impact on Per and Postoperative Opioid Consumption

NCT ID: NCT03107585

Last Updated: 2017-04-11

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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The investigators included prospectively 35 patients undergoing an intermediate cervical block under ultrasound (GP1) before a thyroidectomy ,compared to a group of 35 patients without a block (GP2).

Detailed Description

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The investigators performed prospective trial with 70 patients randomized in two groups each of 35:

* Group 1 (GP1): bilateral echo-guided intermediate cervical plexus bloc (ICB) by 10 ml of isobaric Bupivacaine (0.25%).
* Group 2 (GP2): control.

Ten minutes after ICB, general anesthesia was realised. Total dose of Remifentanil is calculated upon awakening, the postoperative pain is determined by visual analog scale from 0 to 10 (VAS) statements to H0, H2, H4, H6, H12 and H24. Whenever VAS is greater than or equal to 4, a morphine titration was administered.

Total dose consumption, side effects and satisfaction are noted at the end of protocol.

Conditions

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Local Anesthesia Analgesia Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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bilateral cervical plexus block (GP1)

arm intervention GP1 : after skin disinfection and oral premedication , ultrasound guided cervical bilateral bloc ,with10 ml of bupivacaine 0.25 was realized in each side of deep cervical space; then general anesthesia was performed with local protocol

Group Type EXPERIMENTAL

bilateral cervical plexus block

Intervention Type PROCEDURE

with a linear probe and after disinfection vascular neck axis are identified at first. At the cricoid cartilage we conducted an apical scan to locate the carotid bifurcation.at this level is carried out a lateral translation to the visibility of the deep cervical space below the sternocleidomastoidien muscle then a needle 50 is introduced in plane. we proceed in inundation of cervical space

control(GP2)

GP2 control no specific intervention only general anesthesia was performed with local protocol

Group Type PLACEBO_COMPARATOR

bilateral cervical plexus block

Intervention Type PROCEDURE

with a linear probe and after disinfection vascular neck axis are identified at first. At the cricoid cartilage we conducted an apical scan to locate the carotid bifurcation.at this level is carried out a lateral translation to the visibility of the deep cervical space below the sternocleidomastoidien muscle then a needle 50 is introduced in plane. we proceed in inundation of cervical space

Interventions

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bilateral cervical plexus block

with a linear probe and after disinfection vascular neck axis are identified at first. At the cricoid cartilage we conducted an apical scan to locate the carotid bifurcation.at this level is carried out a lateral translation to the visibility of the deep cervical space below the sternocleidomastoidien muscle then a needle 50 is introduced in plane. we proceed in inundation of cervical space

Intervention Type PROCEDURE

Other Intervention Names

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GP1

Eligibility Criteria

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Inclusion Criteria

* candidate for thyroidectomy
* reoperation l

Exclusion Criteria

* no consent
* BMI\> 34
* allergy to any of the products used
* reoperation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Mahdia

OTHER

Sponsor Role lead

Responsible Party

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Majdoub Ali MD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ali majdoub, PHD

Role: PRINCIPAL_INVESTIGATOR

tunisian ministery of health

Locations

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Mahdia University Hospital

Mahdia, Mahdia Governorate, Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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CBTCpood

Identifier Type: -

Identifier Source: org_study_id

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