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

NCT03107585 | Completed

• 1 other identifier: CBTCpood
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Local Anesthesia; Analgesia Disorder

Keywords

cervical plexus block; thyroidectomy; opioid consumption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• postoperative opioid consumption

  first 24 hours after surgery

Study Arms (2)

bilateral cervical plexus block (GP1)

EXPERIMENTAL

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

Procedure: bilateral cervical plexus block

control(GP2)

PLACEBO COMPARATOR

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

Procedure: bilateral cervical plexus block

Interventions

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

Also known as: GP1

bilateral cervical plexus block (GP1); control(GP2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• candidate for thyroidectomy
• reoperation l

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Mahdia: lead

Study Sites (1)

Mahdia University Hospital

Mahdia, Mahdia Governorate, 5100, Tunisia

Location

Study Officials

• ali majdoub, PHD

  tunisian ministery of health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: April 11, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)