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Analgesic Effect Of Preanesthetic Duloxetine Versus Pregabalin As Adjuvants To Ultrasound-Guided Bilateral Superficial Cervical Plexus Block In Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial

Analgesic Effect Of Preanesthetic Duloxetine Versus Pregabalin As Adjuvants To Ultrasound-Guided Bilateral Superficial Cervical Plexus Block In Patients Undergoing Total Thyroidectomy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603707337806
Enrollment
51
Registered
2026-03-16
Start date
2026-03-20
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Cancer Anaesthesia

Interventions

Duloxetine
Pregabalin
control

Sponsors

Primary Sponsor
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: o Patients aged 18 – 65 years, and both sexes. o ASA physical status I &? o Scheduled for elective total thyroidectomy

Exclusion criteria

Exclusion criteria: o Patient refusal. o Known allergy or contraindication to study drugs (bupivacaine, duloxetine, pregabalin, fentanyl, morphine). o Coagulopathy or bleeding disorders. o Infection at the site of block. o Pregnancy and lactation. o Chronic pain syndromes or chronic opioid use. o Psychiatric disorders including major depressive disorder, anxiety disorders, or cognitive impairment preventing proper assessment. o Current use of serotonergic medications (SSRIs, SNRIs, MAOIs, triptans) o Cardiovascular disease (uncontrolled hypertension, heart failure). o Glaucoma or Hepatic dysfunction (ALT/AST > 2 times upper limit of normal). o Severe renal dysfunction (CrCl < 30 mL/min) - both drugs require dose adjustment o History of seizures or epilepsy.

Design outcomes

Primary

MeasureTime frame
Time from end of surgery (defined as completion of skin closure) to first request for rescue analgesia (minutes).

Secondary

MeasureTime frame
• VAS pain scores (0-10 scale) at rest at: 1, 2, 4, 6, 8, 12, 24, at rest and on swallowing postoperatively • Peak pain score in first 24 hours • Intraoperative fentanyl consumption (total mcg) • Total morphine consumption in first 24 hours postoperatively (mg) • Number and percentage of patients requiring rescue analgesia • Time to first rescue analgesic request (primary outcome) • Heart rate (beats/minute) • Systolic blood pressure (mmHg) • Diastolic blood pressure (mmHg) • Mean arterial pressure (mmHg) • Recorded at: baseline (preoperative), 1, 2, 4, 6, 8, 12, 24, and 48 hours postoperatively • Time to first ambulation (hours from end of surgery) • Hospital length of stay (days) • Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively (scale 0-150, higher scores indicate better recovery) • Patient satisfaction score at 48 hours (5-point Likert scale: 1 = very dissatisfied , 5 = very satisfied) • Postoperative nausea and vomiting (PONV): incidence and severity using 4-point scale (0 = none, 1 = nausea only, 2 = one episode of vomiting, 3 = multiple episodes) • Sedation: Ramsay Sedation Scale (1-6) at 1, 2, 4, 6, 8, 12, 24, and

Countries

Egypt

Contacts

Public Contactahmed mohasseb mohasseb

Lecturer of Anesthesia

A_medhat88@mans.edu.eg+201001272216

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026