ClinicalTrials.gg
RecruitingNCT07789548ICPBUpdated Sep 1, 2026

Comparison Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block

A Phase 4 interventional study of Bupivacain only and Bupivacain only in Post Operative Pain Relief After Thyroidectomy, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.

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Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 108 studies in Pain, Postoperative by Assiut University — 30 open to participants now, 31 under way, 5 of them phase 3. Pain, Postoperative · Assiut University.

Planned enrollment
57th of 107
60 · median 70
Started
2026
with 16 others
Phase 4
10 of 108
8 open now
Primary completion
2028-09
later than 27 of 30 live
Registered
98th of 108
by date

Among the 108 studies in Pain, Postoperative by Assiut University, this one is the 57th largest by planned enrollment of the 107 interventional ones that give a count, is one of 17 that started in 2026, is one of 10 in phase 4, reaches primary completion later than 27 of the 30 other live ones, and was the 98th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,231 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

30 of the 108 studies in Pain, Postoperative by Assiut University are open now, in 1 country. Recruiting first, the newest first:

24 more — sign in →

By country, each count listing its studies:

All 30 open studies →

Where they have run

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 240 (35%) set no upper age limit and 329 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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. 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

03

Conditions studied

  • Post Operative Pain Relief After Thyroidectomy

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged between 18 and 65 years.
  • Patients scheduled for elective thyroidectomy under general anesthesia.
  • (ASA) physical status I-II.
  • Both sexes will be included.
  • Patients able to understand the study protocol and provide written .

Exclusion criteria

Exclusion Criteria:

  • Patient refusal.
  • Other endocrine diseases (as uncontrolled diabetes mellitus, adrenal disorders, pituitary disorders)
  • Known allergy or 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.
  • Significant chronic respiratory disease affecting pulmonary function (e.g., severe , restrictive lung disease, uncontrolled asthma).
  • Morbid obesity ( ≥ 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..
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Low-Volume Group

    Ultrasound-guided bilateral intermediate cervical plexus block using 5 mL of bupivacaine0.5% .on each side.

    Drug: Bupivacain only

  • Active comparator
    Standard-Volume Group

    Ultrasound-guided bilateral intermediate cervical plexus block using 10 mL of bupivacaine 0.25% . on each side.

    Drug: Bupivacain only

Interventions

  • DrugBupivacain only

    Bilateral intermediate cervical plexus block using ultrasound-guided bupivacaine 0.5% for low volume group

  • DrugBupivacain only

    Bilateral intermediate cervical plexus block using ultrasound-guided bupivacaine 0.25% for standard group

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline before block, 30 minutes after block.4 hour after block

Secondary outcomes

  1. Postoperative Pain Score visual analog scale (vas)

    Postoperative pain assessed using the Visual Analog Scale (VAS, 0-10) at rest and during swallowing.

    Time frame: Postoperative pain score PACU arrival (0 hour), 6 hour, 12 hour, and 24 hour postoperatively

  2. Total opioid consumption in 24hr postoperative

    Total amount of opioid consumption in patient undergoing thyroidectomy for first 24hr postoperative

    Time frame: After 24hour PACu arrival

07

Study locations

1 of 1 sites recruiting
  • Assiut main university hospital
    Asyut, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.

Of 532 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 24 months is above that.

Counting every sponsor, half of 542 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 27, 2026
StartActual
Sep 1, 2026
Primary completionEst.
Sep 25, 2028
CompletionEst.
Oct 25, 2028
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789548
Lead sponsor
Assiut University
Responsible party
Ahmed Abdelnaeem Abdelsalam Mohammed (Assistant lecturer, Assiut University) — Principal investigator
First posted
Aug 27, 2026
Start date
Sep 1, 2026
Primary completion
Sep 25, 2028 (estimated)
Completion
Oct 25, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Ahmed A Abdelsalam, Master
Contact
ahmed.alraany@gmai.com
+201010227300
Nashua F Abdelhafaz, MD
Contact
nashwaabdeln7@aun.edu.eg
+20 10 19446524
Mostafa S Samy, MD
principal investigator · Assiut university faculty of medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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