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ID
Source
Brief title
Health condition
symptomatic uterine leiomyomata
embolization
post procedural pain
epidural analgesia
patient controlled analgesia
Sponsors and support
Intervention
Outcome measures
Primary outcome
- painrelief (NRS)
Secondary outcome
- factors predicting amount of pain:
amount of embolization material used
reduction of volume of uterine leiomyoma
others:
- hospital stay
- costs
- adverse effects of analgesia
- patient overall satisfaction
- number of readmissions because of pain
Background summary
INTRODUCTION
During and after uterine artery embolization for uterin leiomyomata most patients experience severe pain, which was not controlled with current pain medication (PCM, diclofenac and dipidolor). Therefore this method was replaced by means of personal controlled analgesia. Unfortunately PCA was not sufficient to reduce pain to acceptable levels. Based on its promising results used in other procedures, we will compare the use of epidural analgesia with PCA.
Study objective
Epidural Analgesia shows promising results in other procedures and is therefore thought to be effective in embolization of uterine leiomyomata as well.
Study design
1. NRS: before, 1, 3, 6, 24 after treatment
2. questionnaire (phone call): 2 and 4
weeks after discharge.
3. overall satisfaction: 3 months after
discharge
Intervention
Uterine artery embolization
group 1: PCA (morphin + ketamin)
group 2: epidural analgesia (bupivacain/naropin)
both groups: PCM, diclofenac, tramadol
Inclusion criteria
1. Women
2. >18 years
3. Premenopausal
4. Symptomatic uterine leiomyoma confirmed by ultrasonography
5. Scheduled (and suitable) for uterine artery embolisation
Exclusion criteria
1. Wish for future pregnancy
2. Allergy to contrast material
3. Suspection of uterine malignancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1474 |
| NTR-old | NTR1543 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |