Effect of single-dose mirogabalin premedication on postoperative movement-evoked pain after open abdominal hysterectomy

Effect of single-dose mirogabalin premedication on postoperative movement-evoked pain after open abdominal hysterectomy: a double-blind, placebo-controlled randomized trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260526001

Enrollment

160

Registered

2026-05-26

Start date

2026-05-28

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Acute postoperative movement-evoked pain after elective open total abdominal hysterectomy. Mirogabalin

Interventions

During the preoperative visit, patients were randomly divided into 2 groups (80 patients each) which are blinded to the patients and anesthesiologists. Patients in the mirogabalin group will receive p

Experimental Drug,Placebo Comparator No treatment

Mirogabalin,Placebo

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-65 years. 2. Scheduled for elective open abdominal hysterectomy. 3. ASA physical status I-III. 4. Capable of using IV-PCA morphine.

Exclusion criteria

Exclusion criteria: 1. Allergy or contraindications to mirogabalin, opioids, or gabapentinoids. 2. Chronic pain disorders requiring long-term strong opioid therapy or daily intake of strong opioids. 3. Preoperative strong opioid or gabapentinoid use. 4. Renal impairment with creatinine clearance <30 mL/min. 5. History of substance abuse or psychiatric illness, or pregnancy. 6. Neurological disorders affecting pain perception. 7. Refusal to participate.

Design outcomes

Primary

Measure	Time frame
Movement-evoked pain at 24 hours postoperatively 24 hours postoperatively Numerical Rating Scale (0-10)	—

Secondary

Measure	Time frame
Movement-evoked pain at Post Anesthesia Care Unit Upon arrival at Post Anesthesia Care Unit Numerical Rating Scale 0-10,Movement-evoked pain at 2 hours postoperatively 2 hours postoperatively Numerical Rating Scale 0-10,Movement-evoked pain at 6 hours postoperatively 6 hours postoperatively Numerical Rating Scale 0-10,Movement-evoked pain at 12 hours postoperatively 12 hours postoperatively Numerical Rating Scale 0-10,Cumulative opioid consumption Within the first 24 hours postoperatively Total cumulative opioid consumption in intravenous morphine equivalents (mg) from intravenous-patient controlled analgesia,Sedation score Postoperative period within 24 hours Sedation score (0, 1, 2, 3, S),Quality of recovery 24 hours postoperatively Quality of recovery -14-Thai (QoR-14-Thai),Patient satisfaction 24 hours postoperatively Satisfaction score 0-5,Adverse events From drug administration until 24 hours postoperatively Incidence of somnolence, dizziness, headache, nausea, blurred vision, gait disturbance, fatigue, constipation, peripheral edema	—

Measure

Time frame

Movement-evoked pain at Post Anesthesia Care Unit Upon arrival at Post Anesthesia Care Unit Numerical Rating Scale 0-10,Movement-evoked pain at 2 hours postoperatively 2 hours postoperatively Numerical Rating Scale 0-10,Movement-evoked pain at 6 hours postoperatively 6 hours postoperatively Numerical Rating Scale 0-10,Movement-evoked pain at 12 hours postoperatively 12 hours postoperatively Numerical Rating Scale 0-10,Cumulative opioid consumption Within the first 24 hours postoperatively Total cumulative opioid consumption in intravenous morphine equivalents (mg) from intravenous-patient controlled analgesia,Sedation score Postoperative period within 24 hours Sedation score (0, 1, 2, 3, S),Quality of recovery 24 hours postoperatively Quality of recovery -14-Thai (QoR-14-Thai),Patient satisfaction 24 hours postoperatively Satisfaction score 0-5,Adverse events From drug administration until 24 hours postoperatively Incidence of somnolence, dizziness, headache, nausea, blurred vision, gait disturbance, fatigue, constipation, peripheral edema

—

Countries

Thailand

Contacts

Public ContactRattaphol Seangrung

Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

rattaphol.ra@gmail.com0816880608

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026