Post Operative Pain Relief After ThyroidectomyPhase 4ICPBNCT07789548
Comparison Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block
A Phase 4 study testing Bupivacain only in people with Post Operative Pain Relief After Thyroidectomy, run by Assiut University at 1 site in Egypt.
Trial summary
Thyroidectomy is commonly associated with mild-to-moderate postoperative pain that may affect respiratory function and recovery. Bilateral intermediate cervical plexus block provides effective analgesia, but larger local anesthetic volumes may increase phrenic nerve spread and diaphragmatic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain Relief After Thyroidectomy
- What is being tested?
- Bupivacain only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 25 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged between 18 and 65 years.
- Patients scheduled for elective thyroidectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Both sexes will be included.
- Patients able to understand the study protocol and provide written informed consent.
Who cannot join
- Patient refusal.
- Other endocrine diseases (as uncontrolled diabetes mellitus, adrenal disorders, pituitary disorders)
- Known allergy or hypersensitivity to local anesthetics.
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.
- Local infection at the site of needle insertion.
- Preexisting diaphragmatic dysfunction or phrenic nerve palsy.
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- Significant chronic respiratory disease affecting pulmonary function (e.g., severe COPD, restrictive lung disease, uncontrolled asthma).
- Morbid obesity (BMI ≥ 35 kg/m²).
- Psychiatric or neurological diseases affecting respiratory muscles.
- Previous neck surgery or anatomical deformity interfering with cervical plexus --block performance or diaphragmatic ultrasound assessment.
- Pregnancy..
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut main university hospital
Asyut
Nashua F Abdelhafaz, MD, +201019446524, nashwaabdeln7@aun.edu.eg
About this study
Official title: Comparison Between Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block for Patients Undergoing Thyroidectomy: A Randomized Controlled Trial.
Thyroidectomy is commonly associated with mild-to-moderate postoperative pain that may affect respiratory function and recovery. Bilateral intermediate cervical plexus block provides effective analgesia, but larger local anesthetic volumes may increase phrenic nerve spread and diaphragmatic dysfunction. Low-volume ultrasound-guided block may provide adequate analgesia while better preserving diaphragmatic function and postoperative respiratory performance
Read the detailed description
Thyroidectomy requires effective perioperative analgesia to facilitate swallowing, coughing, deep breathing, and early mobilization. Bilateral intermediate cervical plexus block improves postoperative pain control and reduces opioid requirements, while ultrasound guidance enhances safety and accuracy. However, larger local anesthetic volumes may increase phrenic nerve involvement and diaphragmatic impairment. Ultrasound assessment of diaphragmatic excursion and thickening fraction provides objective evaluation of respiratory function. Low-volume block may preserve diaphragmatic function while maintaining satisfactory analgesic efficacy
- Being tested
- Bupivacain only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain onlyDrug
Bilateral intermediate cervical plexus block using ultrasound-guided bupivacaine 0.5% for low volume group
Bupivacain onlyDrug
Bilateral intermediate cervical plexus block using ultrasound-guided bupivacaine 0.25% for standard group
| Study group | Role | What they receive |
|---|---|---|
| Low-Volume Group | Active comparator | Ultrasound-guided bilateral intermediate cervical plexus block using 5 mL of bupivacaine0.5% .on each side. Receives: Drug: Bupivacain only |
| Standard-Volume Group | Active comparator | Ultrasound-guided bilateral intermediate cervical plexus block using 10 mL of bupivacaine 0.25% . on each side. Receives: Drug: Bupivacain only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaphragmatic excursion in patient undergoing thyroidectomy
Ultrasound-measured diaphragmatic excursion (cm), assessed at baseline before block and at predefined postoperative time points, to compare the effect of low-volume versus standard-volume bilateral intermediate cervical plexus block on diaphragmatic function.
Measured: Baseline before block, 30 minutes after block.4 hour after block
Secondary outcomes (2)
Postoperative Pain Score visual analog scale (vas)
Postoperative pain assessed using the Visual Analog Scale (VAS, 0-10) at rest and during swallowing.
Measured: Postoperative pain score PACU arrival (0 hour), 6 hour, 12 hour, and 24 hour postoperatively
Total opioid consumption in 24hr postoperative
Total amount of opioid consumption in patient undergoing thyroidectomy for first 24hr postoperative
Measured: After 24hour PACu arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026
- Primary completion25 Sep 2028 (estimated)
- Study completion25 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain Relief After ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- Ultrasound-guided bilateral intermediate cervical plexus block with bupivacaine
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelnaeem Abdelsalam Mohammed, Assiut University
- Investigators
- Mostafa S Samy, MD, Principal investigator, Assiut university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789548
- Sponsor's protocol ID
- 04-2026-100512
- Acronym
- ICPB
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block for Patients Undergoing Thyroidectomy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07789548
- Acronym / sponsor ID
- ICPB / 04-2026-100512
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 25 Sep 2028 (estimated)
- Study completion
- 25 Oct 2028 (estimated)
- First posted
- 27 Aug 2026 (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.
Thyroidectomy is commonly associated with mild-to-moderate postoperative pain that may affect respiratory function and recovery. Bilateral intermediate cervical plexus block provides effective analgesia, but larger local anesthetic volumes may increase phrenic nerve spread and diaphragmatic dysfunction. Low-volume ultrasound-guided block may provide adequate analgesia while better preserving diaphragmatic function and postoperative respiratory performance
Detailed description
Thyroidectomy requires effective perioperative analgesia to facilitate swallowing, coughing, deep breathing, and early mobilization. Bilateral intermediate cervical plexus block improves postoperative pain control and reduces opioid requirements, while ultrasound guidance enhances safety and accuracy. However, larger local anesthetic volumes may increase phrenic nerve involvement and diaphragmatic impairment. Ultrasound assessment of diaphragmatic excursion and thickening fraction provides objective evaluation of respiratory function. Low-volume block may preserve diaphragmatic function while maintaining satisfactory analgesic efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Ultrasound-guided bilateral intermediate cervical plexus block with bupivacaine
| Arm | Type | Receives |
|---|---|---|
| Low-Volume Group | Active comparator | Drug: Bupivacain onlyUltrasound-guided bilateral intermediate cervical plexus block using 5 mL of bupivacaine0.5% .on each side. |
| Standard-Volume Group | Active comparator | Drug: Bupivacain onlyUltrasound-guided bilateral intermediate cervical plexus block using 10 mL of bupivacaine 0.25% . on each side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged between 18 and 65 years.
- Patients scheduled for elective thyroidectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Both sexes will be included.
- Patients able to understand the study protocol and provide written informed consent.
Key exclusion criteria (11 listed)
- Patient refusal.
- Other endocrine diseases (as uncontrolled diabetes mellitus, adrenal disorders, pituitary disorders)
- Known allergy or hypersensitivity to local anesthetics.
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.
- Local infection at the site of needle insertion.
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 |
|---|---|---|
| Bupivacain onlyBilateral intermediate cervical plexus block using ultrasound-guided bupivacaine 0.5% for low volume group | Drug | Low-Volume Group |
| Bupivacain onlyBilateral intermediate cervical plexus block using ultrasound-guided bupivacaine 0.25% for standard group | Drug | Standard-Volume Group |
Primary outcome
Change in diaphragmatic excursion in patient undergoing thyroidectomy
Time frame: Baseline before block, 30 minutes after block.4 hour after block
Ultrasound-measured diaphragmatic excursion (cm), assessed at baseline before block and at predefined postoperative time points, to compare the effect of low-volume versus standard-volume bilateral intermediate cervical plexus block on diaphragmatic function.
2 secondary outcomes
Postoperative Pain Score visual analog scale (vas)
Time frame: Postoperative pain score PACU arrival (0 hour), 6 hour, 12 hour, and 24 hour postoperatively
Total opioid consumption in 24hr postoperative
Time frame: After 24hour PACu arrival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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.
Mostafa S Samy, MD principal investigator
Assiut university faculty of medicine
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 Bupivacain only in people with Post Operative Pain Relief After Thyroidectomy, run by Assiut 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 1 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Abdelsalam, Master (+201010227300, ahmed.alraany@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diaphragmatic excursion in patient undergoing thyroidectomy (time frame: Baseline before block, 30 minutes after block.4 hour after block). 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 1 Sep 2026.