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

Local Anesthesia Clinical Trial

— ICPBUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107585
• Other study ID #: CBTCpood
• Status: Completed
• Phase: N/A
• First received: January 13, 2016
• Last updated: April 4, 2017
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2017
• Source: University Hospital, Mahdia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• candidate for thyroidectomy

• reoperation l

Exclusion Criteria:

• no consent

• BMI> 34

• allergy to any of the products used

• reoperation

Related Conditions & MeSH terms

• Analgesia Disorder
• Local Anesthesia

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Tunisia	Mahdia University Hospital	Mahdia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peroperative opioid consumption	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.	opioid consumption during surgery
Secondary	postoperative opioid consumption	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	first 24 hours after surgery