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

U

University Hospital, Mahdia

Status

Completed

Conditions

Local Anesthesia
Analgesia Disorder

Treatments

Procedure: bilateral cervical plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT03107585
CBTCpood

Details and patient eligibility

About

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).

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • candidate for thyroidectomy
  • reoperation l

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups, including a placebo group

bilateral cervical plexus block (GP1)
Experimental group
Description:
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
Treatment:
Procedure: bilateral cervical plexus block
control(GP2)
Placebo Comparator group
Description:
GP2 control no specific intervention only general anesthesia was performed with local protocol
Treatment:
Procedure: bilateral cervical plexus block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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