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Evaluation of most adequate pain medication in uterine artery embolisation for fibroma: PCA versus Epidural Analgesia.


- candidate number4545
- NTR NumberNTR1543
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2008
- Secondary IDs 
- Public TitleEvaluation of most adequate pain medication in uterine artery embolisation for fibroma: PCA versus Epidural Analgesia.
- Scientific TitlePCA and ketamin versus Epidural Analgesia in pain management of uterine artery embolization in symptomatic uterine leiomyomata.
- ACRONYMPALE
- hypothesisEpidural Analgesia shows promising results in other procedures and is therefore thought to be effective in embolization of uterine leiomyomata as well.
- Healt Condition(s) or Problem(s) studiedUterine leiomyomata, Analgesia, Embolisation , Epidural analgesia, Fibroma
- Inclusion criteria1. Women
2. >18 years
3. Premenopausal
4. Symptomatic uterine leiomyoma confirmed by ultrasonography
5. Scheduled (and suitable) for uterine artery embolisation
- Exclusion criteria1. Wish for future pregnancy
2. Allergy to contrast material
3. Suspection of uterine malignancy
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-apr-2009
- planned closingdate6-apr-2010
- Target number of participants100
- InterventionsUterine artery embolization
group 1: PCA (morphin + ketamin)
group 2: epidural analgesia (bupivacain/naropin)
both groups: PCM, diclofenac, tramadol
- 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
- Timepoints1. 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
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Nanda Meents
- CONTACT for SCIENTIFIC QUERIES Nanda Meents
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Onze Lieve Vrouwe Gasthuis (OLVG)
- PublicationsN/A
- Brief summaryINTRODUCTION
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.
- Main changes (audit trail)
- RECORD18-nov-2008 - 28-nov-2008


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