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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

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

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

02

Conditions studied

  • Post Operative Pain Relief After Thyroidectomy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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..
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Assiut main university hospital
    Asyut, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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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