Cervical Plexus BlockPhase 4NCT06621836
Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Thyroid Surgeries Using Two Bupivacaine Concentrations Non Inferiority Trial
A Phase 4 study testing ICPB H and ICPB - L in people with Cervical Plexus Block, run by Cairo University at 1 site in Egypt.
Trial summary
Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during thyroid surgeries. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Plexus Block
- What is being tested?
- ICPB H and ICPB - L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Aug 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III,
- scheduled for Thyroidectomy
Who cannot join
- Heart failure,
- A history of arrhythmias or treatment with antiarrhythmic drugs,
- Impaired pulmonary, liver or kidney function,
- Neck infection or rash
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Thyroid Surgeries Using Two Bupivacaine Concentrations. Non-inferiority Trial
Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during thyroid surgeries. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. A recent randomized trial investigated the analgesic efficacy of superficial vs intermediate CPB combined with GA during total thyroidectomy. The authors used 10 mL of 0.25% bupivacaine bilaterally, and they revealed a lower pain score and prolonged duration of analgesia with ICPB compared to superficial CPB; however, the authors did not assess the influence of this bupivacaine concentration on diaphragmatic motion. [5] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined with GA using two bupivacaine concentrations in patients undergoing thyroid surgery. We hypothesize that a smaller concentration of bupivacaine (0.185%) could provide an equivalent analgesic effect to a larger concentration (0.25%) with less impact on diaphragmatic motion. The primary endpoint is the duration of postoperative analgesia. The secondary endpoints are the intraoperative hemodynamics, the postoperative pain score, total postoperative opioid consumption over 24 hours, diaphragmatic motions, and hemi-diaphragmic paresis.
- Conditions
- Cervical Plexus Block
- Being tested
- ICPB H, ICPB - L
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICPB HDrug
ICPB technique The patient's head will be rested on a pillow and turned to the opposite side. A linear probe with higher frequencies will be placed transversely over the midpoint of the SCM muscle. The carotid artery will be identified and traced upwards to its bifurcation. the probe will be then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle will be advanced underneath the investing fascia of SCM muscle and above the interscalene groove until feeling the "pop" on piercing the investing fascia. The patient will be then randomly allocated into two groups (H \& L) using computer-generated random numbers that will be concealed in opaque envelopes. Group H will receive 10 ml 0.25 % bupivacaine he technique will be repeated on the opposite side
ICPB - LDrug
ICPB technique The patient's head will be rested on a pillow and turned to the opposite side. A linear probe with higher frequencies will be placed transversely over the midpoint of the SCM muscle. The carotid artery will be identified and traced upwards to its bifurcation. the probe will be then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle will be advanced underneath the investing fascia of SCM muscle and above the interscalene groove until feeling the "pop" on piercing the investing fascia. The patient will be then randomly allocated into two groups (H \& L) using computer-generated random numbers that will be concealed in opaque envelopes. Group L will receive 10 ml 0.125% bupivacaine. The technique will be repeated on the opposite side
| Study group | Role | What they receive |
|---|---|---|
| Group-H | Active comparator | Not described Receives: Drug: ICPB H |
| Group-L | Active comparator | Not described Receives: Drug: ICPB - L |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of analgesia
Measured: Time elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2025
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Plexus BlockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621836
- Sponsor's protocol ID
- MS-425-2023
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Thyroid Surgeries Using Two Bupivacaine Concentrations. Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06621836
- Acronym / sponsor ID
- MS-425-2023
- Conditions
- Cervical Plexus Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 1 Oct 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.
Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during thyroid surgeries. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. A recent randomized trial investigated the analgesic efficacy of superficial vs intermediate CPB combined with GA during total thyroidectomy. The authors used 10 mL of 0.25% bupivacaine bilaterally, and they revealed a lower pain score and prolonged duration of analgesia with ICPB compared to superficial CPB; however, the authors did not assess the influence of this bupivacaine concentration on diaphragmatic motion. [5] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined with GA using two bupivacaine concentrations in patients undergoing thyroid surgery. We hypothesize that a smaller concentration of bupivacaine (0.185%) could provide an equivalent analgesic effect to a larger concentration (0.25%) with less impact on diaphragmatic motion. The primary endpoint is the duration of postoperative analgesia. The secondary endpoints are the intraoperative hemodynamics, the postoperative pain score, total postoperative opioid consumption over 24 hours, diaphragmatic motions, and hemi-diaphragmic paresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-H | Active comparator | Drug: ICPB H |
| Group-L | Active comparator | Drug: ICPB - L |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I-III,
- scheduled for Thyroidectomy
Key exclusion criteria (4 listed)
- Heart failure,
- A history of arrhythmias or treatment with antiarrhythmic drugs,
- Impaired pulmonary, liver or kidney function,
- Neck infection or rash
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 |
|---|---|---|
| ICPB HICPB technique The patient's head will be rested on a pillow and turned to the opposite side. A linear probe with higher frequencies will be placed transversely over the midpoint of the SCM muscle. The carotid artery will be identified and traced upwards to its bifurcation. the probe will be then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle will be advanced underneath the investing fascia of SCM muscle and above the interscalene groove until feeling the "pop" on piercing the investing fascia. The patient will be then randomly allocated into two groups (H \& L) using computer-generated random numbers that will be concealed in opaque envelopes. Group H will receive 10 ml 0.25 % bupivacaine he technique will be repeated on the opposite side | Drug | Group-H |
| ICPB - LICPB technique The patient's head will be rested on a pillow and turned to the opposite side. A linear probe with higher frequencies will be placed transversely over the midpoint of the SCM muscle. The carotid artery will be identified and traced upwards to its bifurcation. the probe will be then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle will be advanced underneath the investing fascia of SCM muscle and above the interscalene groove until feeling the "pop" on piercing the investing fascia. The patient will be then randomly allocated into two groups (H \& L) using computer-generated random numbers that will be concealed in opaque envelopes. Group L will receive 10 ml 0.125% bupivacaine. The technique will be repeated on the opposite side | Drug | Group-L |
Primary outcome
The duration of analgesia
Time frame: Time elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 hours
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 27 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICPB H and ICPB - L in people with Cervical Plexus Block, 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 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 27 Oct 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The duration of analgesia (time frame: Time elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 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 27 Oct 2026.