Local AnesthesiaICPBUSNCT03107585
Intermediate Cervical Block Under Ultrasound for Thyroid Surgery: Impact on Per and Postoperative Opioid Consumption
A study testing bilateral cervical plexus block in people with Local Anesthesia and Analgesia Disorder, run by University Hospital, Mahdia at 1 site in Tunisia.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Local Anesthesia, Analgesia Disorder
- What is being tested?
- bilateral cervical plexus block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate for thyroidectomy
- reoperation l
Who cannot join
- no consent
- BMI> 34
- allergy to any of the products used
- reoperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Intermediate Cervical Plexus Block Under Ultrasound for Thyroid Surgery: Impact on Perioperative Opioid Consumption
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).
Read the 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.
- Conditions
- Local Anesthesia, Analgesia Disorder
- Being tested
- bilateral cervical plexus block
- Keywords
- cervical plexus block, thyroidectomy, opioid consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral cervical plexus blockProcedure or surgery
Also called GP1
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: bilateral cervical plexus block |
| control(GP2) | Placebo comparator | GP2 control no specific intervention only general anesthesia was performed with local protocol Receives: Procedure: bilateral cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: opioid consumption during surgery
Secondary outcomes (1)
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
Measured: first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Mahdia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majdoub Ali MD, University Hospital, Mahdia
- Investigators
- ali majdoub, PHD, Principal investigator, tunisian ministery of health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107585
- Sponsor's protocol ID
- CBTCpood
- Acronym
- ICPBUS
- Status last verified
- Apr 2017
- First submitted
- 13 Jan 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Intermediate Cervical Plexus Block Under Ultrasound for Thyroid Surgery: Impact on Perioperative Opioid Consumption
- ClinicalTrials.gov ID
- NCT03107585
- Acronym / sponsor ID
- ICPBUS / CBTCpood
- Conditions
- Local Anesthesia, Analgesia Disorder
- Keywords
- cervical plexus block, thyroidectomy, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MahdiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral cervical plexus block (GP1) | Experimental | Procedure: bilateral cervical plexus blockarm 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 |
| control(GP2) | Placebo comparator | Procedure: bilateral cervical plexus blockGP2 control no specific intervention only general anesthesia was performed with local protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- candidate for thyroidectomy
- reoperation l
Key exclusion criteria (4 listed)
- no consent
- BMI> 34
- allergy to any of the products used
- reoperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral cervical plexus blockAlso: GP1with 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 | Procedure or surgery | bilateral cervical plexus block (GP1), control(GP2) |
Primary outcome
peroperative opioid consumption
Time frame: 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.
1 secondary outcome
postoperative opioid consumption
Time frame: first 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ali majdoub, PHD principal investigator
tunisian ministery of health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral cervical plexus block in people with Local Anesthesia and Analgesia Disorder, run by University Hospital, Mahdia at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peroperative opioid consumption (time frame: opioid consumption during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.