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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Thyroidectomy
• Intervention / Treatment: Procedure: Superficial cervical plexus block; Drug: Ketamine perfusion

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Nabeul Governorate
    • Nabeul, Nabeul Governorate, Tunisia, 8000
      • Mohamed Taher Maamouri University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BCS Group; Patients received a bilateral ultrasound-guided superficial cervical plexus block after induction (Ropivacaine 0.2%,with a volume of 10 mL administered to each side)	Procedure: Superficial cervical plexus block; 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
Active Comparator: KETA group; Patients received intravenous ketamine (0.25 mg/kg bolus followed by a 2 µg/kg/min infusion).	Drug: Ketamine perfusion; Intravenous ketamine 0.25 mg/kg bolus followed by a 2 µg/kg/min infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of chronic neuropathic pain at three months	The incidence of chronic neuropathic pain at three months after thyroidectomy, as determined by the DN4 questionnaire.	three months after thyroidectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery	Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.	24 hours after surgery.
Twenty-four hour postoperative rescue analgesia requirements	The total amount of extra, on-demand pain medication a patient needed in the first 24 hours after their surgery was completed.	within the first 24 hours after the thyroidectomy.
Intraoperative sufentanil consumption	The secondary endpoints included intraoperative sufentanil consumption and reinjection requirements.	During the intraoperative period
Postoperative sleep quality	Sleep quality was assessed 24 hours postoperatively to accurately reflect the effects of analgesia, utilizing the Athens Insomnia Scale (AIS) score.	During the first 24 postoperative hours.
The Observer's Assessment of Alertness/Sedation (OAA/S) within a 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.	2-hour timeframe following thyroidectomy

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: ibtissem BEN TALEB, University of Tunis El Manar, Anesthesia and critical care department, Taher Maamouri University Hospital,

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Actual): April 25, 2025
• Study Completion (Actual): July 5, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Ketamine; Thyroidectomy; Cervical block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: Thyrobloket

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No