NIPH Clinical Trials Search

Efficacy of Paracervical Block During Intracavitary Brachytherapy for Cervical Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Uterine Cervical Cancer
Date of first enrollment	26/12/2025
Target sample size	36
Countries of recruitment
Study type	Interventional
Intervention(s)	All patients will receive the following medications:Diclofenac suppository, Pentazocine , Hydroxyzine, Midazolam. The comparative intervention for the paracervical block(PCB) will be the following two conditions, and each patient will receive both conditions in a crossover design: Group A: Lidocaine infusion in period 1 and placebo (saline) in period 2. Group B: Placebo infusion in Period 1, lidocaine infusion in Period 2

Outcome(s)

Primary Outcome

NRS at Tandem insertion(T2)

Secondary Outcome

1. NRS at speculum insertion (T1), ovoid or cylinder insertion (T3), applicator removal (T4), and leaving a room (T5) 2. Modified CPOT (facial expression, body movement, vocalization) at T1-T4 3. RASS at T1-T4 4. Total dose of midazolam (mg) 5. Adverse events related to sedation and analgesia 6. Adverse events related to the procedure 7. Japanese version of the State-Trait Anxiety Inventory (STAI-State) 8. Japanese version of the Client Satisfaction Questionnaire (CSQ-8J)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	1. Age 18 years at the time of consent 2. Written informed consent has been obtained from each patient 3. Histologically confirmed cervical cancer 4. Scheduled to undergo CCRT or RT as initial or recurrent treatment 5. Scheduled for two or more intracavitary irradiations with tandem applicators and ovoid applicators or cylinders
Exclude criteria	1. Post-hysterectomy patients 2. Known allergy to study-related medications 3. ASA Physical Status Class 3 or higher 4. High risk of upper airway obstruction (e.g. BMI greater than 35 kg/m2, SAS) 5. Cognitive impairment or other conditions precluding pain or questionnaire evaluation 6. Deemed inappropriate for inclusion by the investigators