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Trial registered on ANZCTR


Registration number
ACTRN12614001253695
Ethics application status
Approved
Date submitted
13/11/2014
Date registered
2/12/2014
Date last updated
2/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Placebo Controlled Study of Superior Hypogastric Nerve Blockade (SHNB) for Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Uterine Fibroids.
Scientific title
A Randomised Placebo Controlled Study of Superior Hypogastric Nerve Blockade (SHNB) for Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Uterine Fibroids.
Secondary ID [1] 285661 0
None
Universal Trial Number (UTN)
U1111-1164-0753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine fibroids 293510 0
Condition category
Condition code
Anaesthesiology 293788 293788 0 0
Pain management
Reproductive Health and Childbirth 293855 293855 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post recruitment, patients will be streamed into one of two treatment arms prior to uterine artery embolisation; superior hypogastric nerve block (SHNB) using bupivacaine 0.5% plus adrenaline at a dose rate of 0.5mg per kilogram body weight, or placebo retroperitoneal injection (normal saline).

Local anaesthetic will be infiltrated to a subumbilical site and either bupivacaine 0.5% plus adrenaline or a placebo (normal saline) will then be injected into the retroperitoneum using a 22g Chiba needle. X-ray confirmation of the landmarks (junction of L5 and S1) will be obtained prior to injection and aspiration through the Chiba needle will be performed to confirm extravascular placement of the needle. Technical success of SHNB will be defined as spread of contrast plus local anaesthetic anterior to the vertebral body of L5.
Intervention code [1] 290603 0
Treatment: Drugs
Comparator / control treatment
All patients will receive a retroperitoneal injection of either bupivicaine 0.5% + adrenaline (treatment group) or normal saline (placebo). The group receiving placebo retroperitoneal injection of normal saline will act as the control group.
Control group
Placebo

Outcomes
Primary outcome [1] 293585 0
Mean postoperative pain intensity measured with a 10 point Visual Analogue Scale (VAS)
Timepoint [1] 293585 0
Measured at 0, 2, 4, 6, 8 and 24 hours post procedure
Primary outcome [2] 293586 0
Time to suitability for discharge, measured by a Modified Post-anaesthetic discharge scoring system (MPADSS)
Timepoint [2] 293586 0
Measured at at 10 hours post procedure
Secondary outcome [1] 311404 0
Patient satisfaction with analgesia, procedure and quality of recovery at 6 weeks post procedure measured with a 10 point VAS
Timepoint [1] 311404 0
6 weeks post procedure
Secondary outcome [2] 311405 0
Cumulative opioid requirement (measured via reference to Abbot (Trademark) Gemstar (Trademark) PCA machine).
Timepoint [2] 311405 0
8 hours post procedure (at time of PCA removal)
Secondary outcome [3] 311406 0
Opioid related side effects (including pruritis, nausea and vomiting) measured with 10 point VAS and the total amount of administered anti-emetic medication
Timepoint [3] 311406 0
24 hours post procedure (at time of discharge)
Secondary outcome [4] 311407 0
Patient experience and symptom burden measured by validated tools including:
* Modified Post-Anaesthetic Discharge Scoring System (MPADSS)
* Visual Analogue Scale (VAS) for pain and nausea assessment
* Patient Satisfaction Survey (also using VAS)
* Edmonton Symptom Assessment Scale (ESAS)
* Decision Regret Scale
Timepoint [4] 311407 0
24 hours post procedure (at time of discharge)

Eligibility
Key inclusion criteria
* Diagnosis of symptomatic leiomyomata and referred for UAE;
* Normal renal function or pre-hydration;
* No allergy to contrast media or pre-treatment.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Viable pregnancy;
* Active infection;
* Known or suspected pelvic malignancy;
* Previous UAE (as increased uterine ischaemia);
* Contrast allergy;
* Allergy/intolerance to one or more of the treatment drugs;
* Allergy to cephalosporins;
* History of alcoholism/Intravenous drug use;
* Diagnosed hepatic disease;
* Renal insufficiency;
* Acute pelvic infection/ Pelvic inflammatory disease;
* Endometriosis;
* Adenomyosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients referred for UAE to Prof Ken Thomson, A/Prof Stuart Lyon or Dr Jim Koukounaras, the study investigators, will be considered for the study.

Patients fulfilling the study criteria will be informed about the study during their initial consultation and will be given a Participant Information and Consent Form to take with them. The potential participants will be told to discuss the study with their referring GP/Gynaecologist and their family and to contact the study coordinators if they decide to volunteer for the study. Consent will be obtained by the study coordinators.
If patients choose to participate, they will be required to sign a consent form.

The placebo (normal saline only) and bupivacaine + adrenaline injections will be pre-randomised by The Alfred’s clinical trials pharmacy. The randomisation code will only be revealed by the clinical trial pharmacy to the investigators after the last patient has been recruited and their procedure completed .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-randomisation of placebo and bupivicaine + adrenaline for retroperitoneal injection will be performed by pharmacy prior to SHNB being performed.
Sequence will be generated by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Investigators will be unaware of the treatment group allocation until the conclusion of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data from a previous UAE pain management study conducted at the Alfred Hospital was used to estimate the sample size. In a randomised controlled study of pre-emptive oxycodone with PCA for pain management post UAE we found that in the control group the mean pain VAS at 6 hours and at discharge (24 hours) was 3.2 mm and 1.3 mm respectively (20% effective difference).
With 180 subjects per group this study should have an 80% power to detect a difference in a continuously normally distributed outcome equivalent to 1/2 standard deviation with a two-sided p-value of 0.05.

Data analysis will involve confirmation of data characteristic followed by appropriate testing. Parametric data will be analysed with student t-testing, while non-parametric variables will be analysed using Wilcoxon Rank Sum testing. Binomial data will be analysed using Chi Squared or Fisher’s Exact testing as appropriate. P <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8902 0
3181 - Windsor
Recruitment postcode(s) [2] 8903 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 290243 0
Hospital
Name [1] 290243 0
Alfred Hospital Research Trusts Small Projects Grant
Country [1] 290243 0
Australia
Primary sponsor type
Individual
Name
Professor Ken Thomson
Address
Alfred Hospital
55 Commercial Rd Prahran
Victoria 3004
Country
Australia
Secondary sponsor category [1] 288948 0
Individual
Name [1] 288948 0
A/Prof Stuart Lyon
Address [1] 288948 0
The Avenue Hospital
40 The Avenue, Windsor
Victoria 3181
Country [1] 288948 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291944 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 291944 0
Ethics committee country [1] 291944 0
Australia
Date submitted for ethics approval [1] 291944 0
26/09/2013
Approval date [1] 291944 0
07/07/2014
Ethics approval number [1] 291944 0
389/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52770 0
Prof Kenneth Thomson
Address 52770 0
Alfred Hospital
55 Commercial Rd Prahran
Victoria 3004
Country 52770 0
Australia
Phone 52770 0
+61 03 9076 2536
Fax 52770 0
Email 52770 0
k.thomson@alfred.org.au
Contact person for public queries
Name 52771 0
Helen Kavnoudias
Address 52771 0
Alfred Hospital
55 Commercial Rd Prahran
Victoria 3004
Country 52771 0
Australia
Phone 52771 0
+61 0413027175
Fax 52771 0
Email 52771 0
h.kavnoudias@alfred.org.au
Contact person for scientific queries
Name 52772 0
Helen Kavnoudias
Address 52772 0
Alfred Hospital
55 Commercial Rd Prahran
Victoria 3004
Country 52772 0
Australia
Phone 52772 0
+61 0413027175
Fax 52772 0
Email 52772 0
h.kavnoudias@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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