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

Not Applicable

Completed

• Conditions: Local Anesthesia; Analgesia Disorder
• Interventions: Procedure: bilateral cervical plexus block

• Registration Number: NCT03107585
• Lead Sponsor: University Hospital, Mahdia

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).

Detailed 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-01-13
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• candidate for thyroidectomy
• reoperation l

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control(GP2)	bilateral cervical plexus block	GP2 control no specific intervention only general anesthesia was performed with local protocol
bilateral cervical plexus block (GP1)	bilateral cervical plexus block	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

Primary Outcome Measures

Name	Time	Method
peroperative opioid consumption	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 Outcome Measures

Name	Time	Method
postoperative opioid consumption	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

Trial Locations

Locations (1)

Mahdia University Hospital; 🇹🇳 Mahdia, Tunisia