Uterine Cervical Cancer Uterine Cervical Cancer
Conditions
Interventions
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
D000773
Sponsors
Nagao Shoji
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS at Tandem insertion(T2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactRyoko Imatani
Okayama University Hospital
Outcome results
None listed