Skip to main content
OpenTrials
Completed

NCT Number: NCT07230392

Superficial Cervical Plexus Block Versus Ketamine in the Prevention of Chronic Pain After Thyroidectomy

The goal of our work is to to compare the effect of preemptive Ketamine administration versus superficial cervical plexus block on the incidence of postoperative neuropathic pain in patients undergoing thyroidectomy

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Thyroidectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mohamed Taher Maamouri University Hospital

Nabeul, Nabeul Governorate, 8000, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 80 years
  • Scheduled for thyroidectomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Able to understand the study procedures and provide written informed consent

Exclusion criteria

  • Known allergy to ketamine or local anesthetics
  • Severe renal impairment with estimated Glomerular Filtration Rate (eGFR) under 30 mL/min
  • History of neurological disorders
  • History of psychiatric illness
  • History of severe cardiac disease (NYHA III-IV) or serious arrhythmias
  • Pregnancy or breastfeeding
  • Morbid obesity (BMI > 40 kg/m²)
  • Cognitive or communication impairment
  • Refusal to participate

Treatment and study plan

Ketamine perfusion

Drug

Intravenous ketamine 0.25 mg/kg bolus followed by a 2 µg/kg/min infusion

Superficial Cervical Plexus Block

Procedure

Bilateral ultrasound-guided superficial cervical plexus block after induction(Ropivacaine 0.2% Ropivacaine 0.2%, with a volume of 10 mL administered to each side) was performed for patients of this group

Primary outcomes

  1. The incidence of chronic neuropathic pain at three months

    Time frame: three months after thyroidectomy

    The incidence of chronic neuropathic pain at three months after thyroidectomy, as determined by the DN4 questionnaire.

Secondary outcomes

  1. Twenty-four hour postoperative rescue analgesia requirements

    Time frame: within the first 24 hours after the thyroidectomy.

    The total amount of extra, on-demand pain medication a patient needed in the first 24 hours after their surgery was completed.

  2. Intraoperative sufentanil consumption

    Time frame: During the intraoperative period

    The secondary endpoints included intraoperative sufentanil consumption and reinjection requirements.

  3. Postoperative sleep quality

    Time frame: During the first 24 postoperative hours.

    Sleep quality was assessed 24 hours postoperatively to accurately reflect the effects of analgesia, utilizing the Athens Insomnia Scale (AIS) score.

  4. Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery

    Time frame: 24 hours after surgery.

    Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.

  5. The Observer's Assessment of Alertness/Sedation (OAA/S) within a 2-hour timeframe following thyroidectomy.

    Time frame: 2-hour timeframe following thyroidectomy

    Patients underwent Observer's Assessment of Alertness/Sedation (OAA/S) assessment within a 2-hour timeframe following thyroidectomy, before being cleared for PACU discharge.

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Comparison of Superficial Cervical Plexus Block and Ketamine in the Prevention of Chronic Pain After Thyroidectomy: Results of a Prospective Randomized Study

Acronym: Thyrobloket

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.