Low-volume vs standard-volume ultrasound-guided bilateral intermediate cervical plexus block for thyroidectomy pain
Official title: Comparison Between Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block for Patients Undergoing Thyroidectomy: A Randomized Controlled Trial.
Run by Assiut University · NCT07789548 · Data updated 2026-11-12
This study tests whether using a smaller amount of local anesthetic on both sides before thyroidectomy can provide good pain relief while better preserving breathing.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | September 25, 2028 |
| Study ends | October 25, 2028 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07789548 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 scheduled for elective thyroidectomy under general anesthesia, ASA I–II, without contraindications to regional anesthesia or diaphragmatic dysfunction.
✕Probably not a fit
Patients with significant preexisting respiratory disease, coagulopathy, or allergies to local anesthetics may not benefit and could be excluded from or harmed by the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults undergoing elective thyroidectomy are randomized to receive either a low-volume or a standard-volume ultrasound-guided bilateral intermediate cervical plexus block with bupivacaine. The aim is to compare analgesic effectiveness and diaphragmatic function, using ultrasound to measure diaphragmatic movement and thickening as an objective respiratory endpoint. The trial seeks to determine if lower volumes maintain pain relief while reducing diaphragmatic impairment and opioid needs after surgery. Safety and accuracy are enhanced by ultrasound guidance, with standard perioperative care otherwise unchanged. Outcomes will inform whether lower volumes are preferable for preserving respiratory function without compromising analgesia.
Why it matters
Potential benefit: If successful, patients could experience adequate pain control with less diaphragmatic impairment and lower opioid consumption after thyroidectomy.
How similar studies have gone: Prior research in regional anesthesia for thyroidectomy shows ultrasound-guided blocks can reduce pain and opioid use, though the superiority of low-volume approaches requires confirmation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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..
Where it's running
-
Assiut main university hospital
Asyut, Egypt Recruiting
Study contacts
- Principal investigator: Mostafa S Samy, MD — Assiut university faculty of medicine
- Study coordinator: Ahmed A Abdelsalam, Master
- Email: ahmed.alraany@gmai.com
- Phone: +201010227300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.