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

Sponsor
University Hospital, Mahdia (Other)
Overall Status
Completed
CT.gov ID
NCT03107585
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
12
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: bilateral cervical plexus block
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Bilateral Intermediate Cervical Plexus Block Under Ultrasound for Thyroid Surgery: Impact on Perioperative Opioid Consumption
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: bilateral cervical plexus block (GP1)

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
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

    		•
    Placebo Comparator: control(GP2)

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

    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
    Other Names:
  • GP1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • candidate for thyroidectomy

    • reoperation l

    Exclusion Criteria:

    • no consent

    • BMI> 34

    • allergy to any of the products used

    • reoperation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahdia University Hospital Mahdia Tunisia 5100

    Sponsors and Collaborators

    • University Hospital, Mahdia

    Investigators

    • Principal Investigator: ali majdoub, PHD, tunisian ministery of health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Majdoub Ali MD, Clinical Professor, University Hospital, Mahdia
    ClinicalTrials.gov Identifier:
    NCT03107585
    Other Study ID Numbers:
    • CBTCpood
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    Apr 11, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Majdoub Ali MD, Clinical Professor, University Hospital, Mahdia
    cervical plexus block
    thyroidectomy
    opioid consumption

    Study Results

    No Results Posted as of Apr 11, 2017