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AnesthesiaNCT06419556

Analgesic Efficacy of an Intermediate CPB in Neck Surgeries.

A study testing Cervical Plexus Block in people with Anesthesia and Thyroid, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to investigate the analgesic efficacy of Intermediate Cervical Plexus Block combined with GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy) Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Anesthesia, Thyroid, Neck
What is being tested?
Cervical Plexus Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteEgypt
Study dates
5 Mar 2023to 1 Jun 2024
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient aged ≥ 40 years
  • ASA physical status I-III scheduled for total thyroidectomy or total laryngectomy under GA.

Who cannot join

  • Patients with heart failure
  • history of arrhythmias
  • treatment with antiarrhythmic drugs
  • impaired pulmonary
  • Liver or kidney functions
  • Neck infection or rash

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Cairo university Hospitals. kasralainy

    Cairo, Governorate, 002

    Nagy malak, 01552480258, nagymalak@kasralainy.edu.eg.com

    Recruiting

Other trials in Egypt

About this study

Official title: Analgesic Efficacy of an Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries. A Comparison Between Two Bupivacaine Concentrations.

This study aims to investigate the analgesic efficacy of Intermediate Cervical Plexus Block combined with GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy)

Read the detailed description

This randomized comparative study was conducted in Cairo University hospitals after the approval of the institutional research and ethics committee. Informed consent was obtained from all participants. The Consolidated Standards of Reporting Trials (CONSORT) Guidelines were followed.

The patients were randomly allocated into two groups (H \& L) using computer generated random numbers that were concealed in opaque envelopes. Group H received 20 ml 0.25 % bupivacaine and Group L received 20 ml 0.125% bupivacaine bilaterally.

  • On arrival to the operating room, an 18G cannula was inserted with the infusion of 500 ml Ringer solution. Controloc 40 mg, ondansetron 8 mg, and dexamethasone 8 mg were administered as premedication. The diaphragmatic motion was assessed by a 3.5 MHz curvilinear transducer, siemens ACUSON X300 ultrasound. Each hemidiaphragm was first visualized by B-mode then M-mode was used to evaluate diaphragmatic excursion. For the right hemidiaphragm, the transducer was placed perpendicularly over the right subcostal margin in the anterior axillary line, the prob was then directed cephalad and dorsally to reach the posterior one-third of the diaphragm. Diaphragmatic excursions were measured and recorded in millimeters using the liver as an acoustic window during quiet breathing. The left hemidiaphragm was assessed in the same way using the spleen as an acoustic window.
  • All patients connected to an electrocardiograph (ECG), pulse oximeter, and non-invasive blood pressure (NIBP), and baseline values of HR and MAP were measured and recorded. Additional monitoring in the form of a capnogram, invasive blood pressure (IBP) through a radial artery cannula, peripheral nerve stimulator (PNS), Bispectral index (BIS), and urine output were connected after induction of GA. Anesthesia was induced by intravenous fentanyl 2µg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg. When the TOF count showed the disappearance of T1 (0/4), an appropriate-size endotracheal tube was inserted and secured. Under complete aseptic conditions, ultrasound guided bilateral ICPB was performed by a single staff anesthetist who is skilled in carrying out regional anesthesia.
  • ICPB technique: The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. The patient was then randomly allocated into two groups (H \& L) using computer generated random numbers that were concealed in opaque envelopes. Group H received 20 ml 0.25 % bupivacaine and Group L received 20 ml 0.125% bupivacaine. The technique was repeated on the opposite side.
  • During the intraoperative period, anesthesia was maintained with isoflurane 1.2-1.5 vol% to keep BIS value at 40-60 and atracurium 0.1mg/kg guided by PNS. Additional doses of fentanyl 0.05 µg/kg were administered when HR or MAP increased > 20% of the baseline values. MAP and HR were measured after the skin incision, and then every 30 minutes till the end of surgery. The failed block was considered when ≥ four additional doses of fentanyl were required to manage the increased MAP or HR after skin incision. At the end of the surgery, one gram of paracetamol plus 30 mg of ketorolac were administered.
  • During the postoperative period, regular analgesia in the form of intravenous paracetamol one gram/8hr was prescribed. Pain severity was assessed by using the visual analog scale (VAS) (0= no pain and 100mm= worst pain) at 2, 4, 6, 8, 12, 18, and 24 hr postoperatively. Rescue analgesia in the form of intravenous morphine 0.05 mg/kg was given on the patient's complaint or when VAS ≥ 40 mm and repeated every 15-20 minutes until VAS < 40 mm with a maximum morphine dose of 40 mg per 24 hours. The duration of analgesia was calculated as the time elapsed from the end of the ICPB block procedure till VAS ≥ 40mm. The total postoperative morphine consumption over 24 hours was calculated. The measurement of diaphragmatic excursions was repeated as mentioned above, hemi-diaphragmatic paresis was divided into three grades, depending on the percentage of diaphragm movement compared with baseline to be: none (> 75%), partial paresis (25-75%), and complete paresis (< 25%)
Being tested
Cervical Plexus Block
Keywords
Neck surgeries, Cervical Plexus Block, Bupivacaine
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Plexus BlockProcedure or surgery

    The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt.

Study groups in NCT06419556
Study groupRoleWhat they receive
Group HExperimentalThe patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. Probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. Group H received 20 ml 0.25 % bupivacaine
Receives: Procedure: Cervical Plexus Block
Group L received 20 ml 0.125% bupivacaineActive comparatorThe patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. Probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. Group L received 20 ml 0.125% bupivacaine.
Receives: Procedure: Cervical Plexus Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of analgesia

    duration of anesthesia and Block-skin incision time differ between two groups (two concentrations of bupivacaine)

    Measured: duration of operation up to 6 hours

Secondary outcomes (5)
  1. The diaphragmatic motions measured by M-mode ultrasonography

    Measured at two-time points: before anesthesia (baseline) and on arrival to PACU, with the calculation of the hemi-diaphragmatic paresis depending on the percentage of diaphragm movement compared with baseline as follows: none (> 75%), partial paresis (25-75%), and complete paresis (< 25%).

    Measured: duration of operation up to 6 hours

  2. Total postoperative Morphine consumption.

    Total postoperative Morphine consumption.

    Measured: 24 hours

  3. The postoperative VAS score

    scale (0= no pain and 100 mm= worst pain) and measured at 2, 4, 6, 8, 12, 18, and 24 hr postoperatively. Rescue analgesia in the form of intravenous morphine 0.05 mg/kg given on the patient's complaint or when VAS ≥ 40 mm and repeated every 15-20 minutes until VAS < 40 mm with a maximum morphine dose of 40 mg per 24 hours.

    Measured: 24 hours

  4. Hemodynamics

    Intraoperative MAP and HR were measured after the skin incision, and then every 30 minutes until the end of surgery.

    Measured: duration of operation up to 6 hours

  5. opioid consumption.

    Intraoperative opioid (fentanyl) consumption.The failed block was considered when ≥ four additional doses of fentanyl were required to manage the increased MAP or HR after skin incision.

    Measured: duration of operation up to 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start5 Mar 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419556
Sponsor's protocol ID
MS-425-2023
Status last verified
May 2024
First submitted
14 May 2024
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cervical Plexus Block in people with Anesthesia and Thyroid, run by Cairo University at 1 site in Egypt.

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 6 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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 Egypt. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nagy malak (01552480258, nagymalak@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of analgesia (time frame: duration of operation up to 6 hours). 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 17 May 2024.

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Clinical Trial NCT06419556 | AzTrials