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Completed

NCT Number: NCT03107585

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

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).

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Key information

Conditions

Local Anesthesia Analgesia Disorder

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahdia University Hospital

Mahdia, Mahdia Governorate, 5100, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • candidate for thyroidectomy
  • reoperation l

Exclusion criteria

  • no consent
  • BMI> 34
  • allergy to any of the products used
  • reoperation

Treatment and study plan

bilateral cervical plexus block

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

Other names: GP1

Primary outcomes

  1. peroperative opioid consumption

    Time frame: opioid consumption during surgery

    In addition to the standard monitoring , we associate that of narcosis (BIS, Covidien LLC.Mansfield, USA) whose level is maintained between 40 and 60, a monitoring of the capnia, maintained between 35 and 40mmHg, we associate an analyzer of gas.The maintenance of the anesthesia is provided by sevoflurane adjusted according to the values of the bi-spectral index. Remifentanil is administered by the electrical pump as a function of the variation in blood pressure and heart rate, which should not exceed 20% of their baseline values during the surgical procedure.All our patients were operated by the same team.

    Ten minutes before closure, each patient receives 1 g of paracetamol (Perfalgan®) and 50 to 100 mg of tramadol depending on his weight. The remifentanil syringe pump is stopped when the skin is closed and the total dose is calculated for each patient.

Secondary outcomes

  1. postoperative opioid consumption

    Time frame: first 24 hours after surgery

    the investigator proceed to evaluate pain at H0, H2, H4, H6, H12 and H24 postoperative hour. Each time the patient had a Visual analogic scale (VAS) greater than or equal to 40mm(from 0 to 100) a titration of 3 mg intravenous morphine every 5 minutes until VAS <40mm . Total dose of morphine required was calculated 24 hours after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Mahdia

Other

Registry information

Official study title

Bilateral Intermediate Cervical Plexus Block Under Ultrasound for Thyroid Surgery: Impact on Perioperative Opioid Consumption

Acronym: ICPBUS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2017
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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