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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07230392
Acronym
Thyrobloket
Enrollment
69
Registered
2025-11-17
Start date
2024-10-14
Completion date
2025-07-05
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Thyroidectomy

Keywords

Ketamine, Thyroidectomy, Cervical block

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

Interventions

DRUGKetamine perfusion

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

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

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Twenty-four hour postoperative rescue analgesia requirementswithin 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.
Intraoperative sufentanil consumptionDuring the intraoperative periodThe secondary endpoints included intraoperative sufentanil consumption and reinjection requirements.
Postoperative sleep qualityDuring 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.
Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery24 hours after surgery.Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.
The Observer's Assessment of Alertness/Sedation (OAA/S) within a 2-hour timeframe following thyroidectomy.2-hour timeframe following thyroidectomyPatients underwent Observer's Assessment of Alertness/Sedation (OAA/S) assessment within a 2-hour timeframe following thyroidectomy, before being cleared for PACU discharge.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026