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

Comparison Between Low-volume Versus Standard-volume Ultrasound-guided Bilateral Intermediate Cervical Plexus Block for Patients Undergoing Thyroidectomy: A Randomized Controlled Trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07789548
Acronym
ICPB
Enrollment
60
Registered
2026-08-27
Start date
2026-09-01
Completion date
2028-10-25
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain Relief After Thyroidectomy

Brief 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

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

Interventions

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Ultrasound-guided bilateral intermediate cervical plexus block with bupivacaine

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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..

Design outcomes

Primary

MeasureTime frameDescription
Change in diaphragmatic excursion in patient undergoing thyroidectomyBaseline before block, 30 minutes after block.4 hour after blockUltrasound-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.

Secondary

MeasureTime frameDescription
Postoperative Pain Score visual analog scale (vas)Postoperative pain score PACU arrival (0 hour), 6 hour, 12 hour, and 24 hour postoperativelyPostoperative pain assessed using the Visual Analog Scale (VAS, 0-10) at rest and during swallowing.
Total opioid consumption in 24hr postoperativeAfter 24hour PACu arrivalTotal amount of opioid consumption in patient undergoing thyroidectomy for first 24hr postoperative

Countries

Egypt

Contacts

CONTACTAhmed A Abdelsalam, Master
ahmed.alraany@gmai.com+201010227300
CONTACTNashua F Abdelhafaz, MD
nashwaabdeln7@aun.edu.eg+20 10 19446524
PRINCIPAL_INVESTIGATORMostafa S Samy, MD

Assiut university faculty of medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026