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.
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
- Recruiting
Cairo university Hospitals. kasralainy
Cairo, Governorate, 002
Nagy malak, 01552480258, nagymalak@kasralainy.edu.eg.com
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%)
- Conditions
- Anesthesia, Thyroid, Neck, Bupivacaine
- 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 group | Role | What they receive |
|---|---|---|
| Group H | Experimental | 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. 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% bupivacaine | Active comparator | 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. 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.
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)
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
Total postoperative Morphine consumption.
Total postoperative Morphine consumption.
Measured: 24 hours
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
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
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.
- First posted17 May 2024
- Study start5 Mar 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Malak , MD, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of an Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries. A Comparison Between Two Bupivacaine Concentrations.
- ClinicalTrials.gov ID
- NCT06419556
- Acronym / sponsor ID
- MS-425-2023
- Conditions
- Anesthesia, Thyroid, Neck, Bupivacaine
- Keywords
- Neck surgeries, Cervical Plexus Block, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 17 May 2024 (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.
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)
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%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group H | Experimental | Procedure: Cervical Plexus BlockThe 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 |
| Group L received 20 ml 0.125% bupivacaine | Active comparator | Procedure: Cervical Plexus BlockThe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient aged ≥ 40 years
- ASA physical status I-III scheduled for total thyroidectomy or total laryngectomy under GA.
Key exclusion criteria (6 listed)
- Patients with heart failure
- history of arrhythmias
- treatment with antiarrhythmic drugs
- impaired pulmonary
- Liver or kidney functions
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 |
|---|---|---|
| Cervical Plexus BlockThe 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. | Procedure or surgery | Group H, Group L received 20 ml 0.125% bupivacaine |
Primary outcome
Duration of analgesia
Time frame: duration of operation up to 6 hours
duration of anesthesia and Block-skin incision time differ between two groups (two concentrations of bupivacaine)
5 secondary outcomes
The diaphragmatic motions measured by M-mode ultrasonography
Time frame: duration of operation up to 6 hours
Total postoperative Morphine consumption.
Time frame: 24 hours
The postoperative VAS score
Time frame: 24 hours
Hemodynamics
Time frame: duration of operation up to 6 hours
opioid consumption.
Time frame: duration of operation up to 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
1 site in 1 country: see every site and its status.
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.