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

NCT07789548 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 04-2026-100512
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain Relief After Thyroidectomy

Outcome Measures

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.

  Baseline before block, 30 minutes after block.4 hour after block

Secondary Outcomes (2)

• Postoperative Pain Score visual analog scale (vas)

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

• Total opioid consumption in 24hr postoperative

  After 24hour PACu arrival

Study Arms (2)

Low-Volume Group

ACTIVE COMPARATOR

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

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.

Drug: Bupivacain only

Interventions

Bupivacain only DRUG

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

Low-Volume Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut main university hospital

Asyut, Egypt

Location

Study Officials

• Mostafa S Samy, MD

  Assiut university faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Abdelsalam, Master

CONTACT

+201010227300; ahmed.alraany@gmai.com

Nashua F Abdelhafaz, MD

CONTACT

+20 10 19446524; nashwaabdeln7@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Ultrasound-guided bilateral intermediate cervical plexus block with bupivacaine

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 25, 2026
• Primary Completion (Estimated): September 25, 2028
• Study Completion (Estimated): October 25, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)