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Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata

18 Years
80 Years
Open (Enrolling)
Uterine Fibroids

Thank you

Trial Information

Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata

Post operative Pain Management in Paitents Undergoing Uterine Artery Embolisation for
Symptomatic Leiomyomata

Protocol (Ver 2.1)

1.1 Research Question Does pre emptive morphine dosing help reduce acute post operative pain
(as expressed on a visual analogue scale, VAS) and/or post operative opioid use in patients
undergoing uterine artery embolisation?

2.1 Enrolment Patients are enrolled by Prof Ken Thomson or Dr Stuart Lyon during a planning
consultation with each woman. They will be required to sign a consent form if they choose to
participate at this point. 3 photocopies of this consent form will be taken, with one copy
to go with: the patient; the history; and the data file.

2.2 Exclusions

Patients with the following should be excluded from the study:

- Pregnancy

- Contrast allergy

- Allergy to one or more of the treatment drugs

- History of alcoholism

- Diagnosed hepatic disease

- Renal insufficiency

- Acute pelvic infection

- Endometrial carcinoma

- Undiagnosed pelvic mass

- Non English speaking patients

- Patients who require post op non opioid analgesia

3.1 Randomisation and blinding The placebo and oxycontinSR tablets have been pre randomised
by the clinical trials pharmacy on LG level (Ann Mak).

4.1 Pre medications The trial drug (oxycontin) will be ordered on a yellow clinical trial
prescription form. A day before the patient arrives, this form should be faxed to the
Clinical Trials Pharmacy (Fax No 3305). A registered nurse from the ward or researcher
should then pick up the drugs from the Clinical Trials Pharmacy on LG level.

The other non trial medications should be either already on the ward or should be ordered
via pharmacy as per normal.

The trial drugs and pre medications will all be written up on a prepared drug chart which
will be given to the ward.

4.2 Treatment

The ward staff will administer the drugs as prescribed on the drug chart 60 +/- 20 minutes
prior to the procedure.

The differences in the treatment is shown on the following table. Dose on demand treatment
Pre emptive treatment

1 hour before surgery:

- Paracetamol 1.5g

- Temazepam 20mg

- Placebo OxycontinSR

- Piroxicam (Feldene) 20mg

- Ondansetron 8mg 1 hour before surgery:

- Paracetamol 1.5g

- Temazepam 20mg

- OxycontinSR

- Piroxicam (Feldene) 20mg

- Ondansetron 8mg


- PCA morphine

- 1mg dose with 5 minute lockout Surgery:

- PCA morphine

- 1mg dose with 5 minute lockout Follow up

- Endone 5-10mg oral 4/24 prn Follow up

- Endone 5-10mg oral 4/24 prn

The ward staff will be blinded as to which treatment the patient receives since the pre meds
are have been randomised and blinded by the pharmacy.

5.1 Post op Pain and nausea measurements will be taken at 2, 4, 6 and 24 hours using the
visual analogue scale (VAS) questionnaire sheets. This can be done either by the
researchers, or if time permits, ward staff.

Drug related side effects are also recorded, such as respiratory depression and vomiting and
it is therefore important for these to be carefully documented in the patient’s history.

5.2 Deviations from pain management protocol There may be instances where the PCA does not
deliver adequate pain relief. It may be necessary in these cases to deviate from the pain
management protocol for the comfort of the patient. This does not necessarily exclude the
patient from the study. However, the way in which the data is interpreted once non opioid
analgesia is given should be done with caution.

Deviations should be instituted when:

- Obvious drug related side effects are evident (e.g. respiratory depression, narcosis);

- Pain is not at an acceptable level at 6 hours post procedure; or

- Pain is not at a level in keeping with routine post UAE pain as reported by nursing or
medical staff.

Please notify Dr Stuart Lyon or Dr Jeff Tam (ex 3606) if the Pain Team needs to intervene
for these patients. They will then assess whether or not the patient will be excluded from
the study.

6.1 Discharge

When patients are deemed ready for discharge they need to take home a discharge pack with
some questionnaires for them to fill out at home. These should be done at 24 hours post
procedure. The pack will include:

- Pain VAS

- Nausea VAS

- Overall pain relief rating VAS

- UAE procedure rating VAS

- Instructions sheet

- Reply paid, self addressed envelope

Please check that the 2, 4 and 6 hour questionnaires have been filled out before the patient
is discharged, and that they leave with the discharge pack. Once completed, the
questionnaires should be sent back to the Radiology Research Department.

Most patients will be discharged within 24 hours of the procedure. In the event that the
patient stays in hospital longer than 24 hours, then the discharge pack should be completed
at the 24 hour mark. The completed data sheets should then be sent back to the Radiology
Research Department.

If the data sheets are not received within 2 weeks of discharge, the researchers should make
a phone call to the patient to enquire whether they have been completed and to answer any
questions the patient may have.

Inclusion Criteria:

- na

Exclusion Criteria:

- na

Type of Study:


Study Design:

Observational Model: Defined Population, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Principal Investigator

Kenneth Thomson, MBBS RANZCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bayside Health


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

January 2005

Completion Date:

December 2007

Related Keywords:

  • Uterine Fibroids
  • Uterine Fibroids
  • embolisation
  • pain management
  • Leiomyoma
  • Myofibroma
  • Pain, Postoperative