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

NCT07230392 | Completed Phase 4

• 1 other identifier: Thyrobloket
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain; Thyroidectomy

Keywords

Ketamine; Thyroidectomy; Cervical block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Twenty-four hour postoperative rescue analgesia requirements

  within the first 24 hours after the thyroidectomy.

• Intraoperative sufentanil consumption

  During the intraoperative period

• Postoperative sleep quality

  During the first 24 postoperative hours.

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

  24 hours after surgery.

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

  2-hour timeframe following thyroidectomy

Study Arms (2)

BCS Group

ACTIVE COMPARATOR

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

KETA group

ACTIVE COMPARATOR

Patients received intravenous ketamine (0.25 mg/kg bolus followed by a 2 µg/kg/min infusion).

Drug: Ketamine perfusion

Interventions

Ketamine perfusion DRUG

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

KETA group

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

BCS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mohamed Taher Maamouri University Hospital

Nabeul, Nabeul Governorate, 8000, Tunisia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ibtissem BEN TALEB

  University of Tunis El Manar, Anesthesia and critical care department, Taher Maamouri University Hospital,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: October 14, 2024
• Primary Completion: April 25, 2025
• Study Completion: July 5, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

TU (1)