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

University Tunis El Manar69 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Chronic Pain Thyroidectomy

Interventions

Ketamine perfusionDRUG

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

Superficial cervical plexus blockPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mohamed Taher Maamouri University Hospital

Nabeul, Nabeul Governorate, Tunisia

Outcomes

Primary Outcomes

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.

Time frame: three months after thyroidectomy

Secondary Outcomes

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.

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

Intraoperative sufentanil consumption

The secondary endpoints included intraoperative sufentanil consumption and reinjection requirements.

Time frame: 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.

Time frame: During the first 24 postoperative hours.

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.

Time frame: 24 hours after surgery.

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.

Time frame: 2-hour timeframe following thyroidectomy

Data from ClinicalTrials.gov

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