Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery

NCT07689617 | Completed

• 1 other identifier: 7996
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the analgesic efficacy of ultrasound-guided intermediate cervical plexus block (ICB) in patients undergoing vagus nerve stimulation (VNS) implantation surgery under general anesthesia. Participants are randomly assigned to receive either an ultrasound-guided ICB with 10 mL of 0.25% bupivacaine or a placebo injection with 10 mL of normal saline following induction of general anesthesia. The primary outcome is total postoperative morphine consumption during the first 24 hours after surgery. Secondary outcomes include intraoperative remifentanil consumption, postoperative pain intensity assessed using the Numeric Rating Scale (NRS), time to first analgesic request, length of hospital stay, and postoperative seizure incidence.

Conditions

Drug-Resistant Epilepsy; Epilepsy; Vagus Nerve Stimulation

Keywords

Vagus Nerve Stimulation; Cervical Plexus Block; Pain, Postoperative; Analgesics, Opioid; Regional Anesthesia; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Total postoperative morphine consumption during the first 24 hours after surgery

  Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).

  24 hours after surgery

Secondary Outcomes (5)

• Intraoperative remifentanil consumption

  From induction of anesthesia until the end of surgery

• Postoperative pain intensity

  From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively

• Time to first rescue analgesic request

  Within 24 hours after surgery

• Length of hospital stay

  From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively

• Postoperative seizure incidence

  Within 24 hours after surgery

Study Arms (2)

Intermediate Cervical Plexus Block

EXPERIMENTAL

Participants received an ultrasound-guided intermediate cervical plexus block with 10 mL of 0.25% bupivacaine after induction of general anesthesia before vagus nerve stimulation implantation surgery.

Procedure: Ultrasound-guided intermediate cervical plexus block; Drug: Bupivacaine

Control

PLACEBO COMPARATOR

Participants received an ultrasound-guided placebo injection with 10 mL of 0.9% normal saline after induction of general anesthesia before vagus nerve stimulation implantation surgery.

Procedure: Ultrasound-guided intermediate cervical plexus block; Drug: Sodium Chloride 0.9% in 10 ml injection

Interventions

Ultrasound-guided intermediate cervical plexus block PROCEDURE

Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.

Control; Intermediate Cervical Plexus Block

Sodium Chloride 0.9% in 10 ml injection DRUG

10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.

Control

Bupivacaine DRUG

10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.

Intermediate Cervical Plexus Block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-60 years
• American Society of Anesthesiologists (ASA) physical status II-III
• Drug-resistant epilepsy
• Scheduled for elective vagus nerve stimulation implantation surgery under general anesthesia
• Written informed consent obtained

You may not qualify if:

• Allergy or contraindication to local anesthetics
• Coagulopathy or current anticoagulant therapy
• Infection at the injection site
• Pregnancy or breastfeeding
• Severe pulmonary disease
• Inability to understand or use the Numeric Rating Scale (NRS)
• Refusal to participate

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat University Faculty of Medicine Hospital

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Pain, Postoperative

Interventions

Sodium Chloride; Injections; Bupivacaine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ahmet Aksu, Assistant Professor

  Fırat University Faculty of Medicine Department of Anaesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, postoperative care providers, and outcome assessors were blinded to treatment allocation. Study solutions were prepared in identical syringes by an independent anesthesiologist not involved in postoperative assessments or data analysis. The anesthesiologist performing the block was aware of the assigned intervention but did not participate in postoperative outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1 ratio to receive either an ultrasound-guided intermediate cervical plexus block with 10 mL of 0.25% bupivacaine or a placebo injection with 10 mL of 0.9% normal saline following induction of general anesthesia. Each participant received only one study intervention.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 8, 2026
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 31, 2023
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)