Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001243707
Ethics application status
Approved
Date submitted
11/11/2013
Date registered
13/11/2013
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the efficacy of anti-inflammatories given by the intravenous route in gynaecologic day case surgery
Scientific title
A comparison of intravenous ibuprofen 800mg, parecoxib 40mg, parecoxib 80mg and placebo in female patients undergoing hysteroscopy +/- dilatation and curettage +/- mirena insertion as day case surgery - a comparison of analgesic efficacy, quality of recovery and incidence of opioid related side effects
Secondary ID [1] 283557 0
Nil
Universal Trial Number (UTN)
Trial acronym
DEFINITIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management following hysteroscopy +/- dilatation and curettage +/- mirena insertion
 290463 0
Condition category
Condition code
Anaesthesiology 290855 290855 0 0
Pain management
Reproductive Health and Childbirth 290876 290876 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Intravenous ibuprofen 800mg single dose at the time of surgery
Arm 2. Intravenous parecoxib 80mg single dose at the time of surgery
Arm 3. Intravenous parecoxib 40mg single dose at the time of surgery
Intervention code [1] 288252 0
Treatment: Drugs
Comparator / control treatment
Intravenous saline 0.9% (placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 290852 0
The efficacy of the analgesic regimen as determined by the highest pain score in the recovery room post operatively.
Timepoint [1] 290852 0
Immediately post-operatively: first recovery pain score (numeric rating score 0-10)
Primary outcome [2] 290853 0
The OBAS (overall benefit of analgesia score), which assesses pain intensity and opioid-related adverse effects (score range 0-28)
Timepoint [2] 290853 0
24 hours post-operatively
Secondary outcome [1] 305442 0
The efficacy of the analgesic regimen as determined by:
a. Pain scores at rest and due to abdominal cramping at one hour, two hours and 24 hours post operatively
b. Highest pain score over the 24-hour period
c. Area under the curve for rest and crampy pain scores over 0-24 hours
Timepoint [1] 305442 0
0-24hours post-operatively
Secondary outcome [2] 305443 0
Time to first rescue analgesia with fentanyl
Timepoint [2] 305443 0
Up to two hours post-operatively
Secondary outcome [3] 305444 0
Cumulative dose of fentanyl (intra & post operatively)
Timepoint [3] 305444 0
Intra-operatively and up to two hours post-operatively
Secondary outcome [4] 305445 0
Time to first dose of tramadol (oral)
Timepoint [4] 305445 0
24 hours
Secondary outcome [5] 305446 0
Cumulative dose of tramadol in 24hr
Timepoint [5] 305446 0
24 hours
Secondary outcome [6] 305447 0
Cumulative dose of paracetamol in 24hr
Timepoint [6] 305447 0
24 hours
Secondary outcome [7] 305448 0
The incidence of nausea and vomiting - yes/no
Timepoint [7] 305448 0
24 hours
Secondary outcome [8] 305449 0
The incidence of itching - yes/no
Timepoint [8] 305449 0
24 hours
Secondary outcome [9] 305450 0
Quality of Recovery (QoR) questionnaire
Timepoint [9] 305450 0
24 hours

Eligibility
Key inclusion criteria
ASA 1 or 2
Undergoing hysteroscopy +/- dilatation and curettage +/- mirena insertion
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal dysfunction
Hypertension
Ischaemic heart disease
Cerebrovascular disease
Past or current peptic ulcer disease
Allergy to non-steroidal anti-inflammatory drugs
Aspirin or NSAID induced asthma
Hepatocellular insufficiency
Unsuitable for general anaesthesia with maintenance with inhalational agent

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 will be identified and enrolled in the pre-anaesthetic ward. Verbal and written consent will be obtained after a thorough explanation of the trials significance and purpose. Patients will be randomized preoperatively using a computer generated random number generator into one of the four intervention groups, using opaque sealed envelopes.
The attending anaesthetist, patients, recovery nurses, staff collecting the data and investigators will be blinded to the group assignment until all of the data has been collected. This will be done by the annotation of “study drug” in the patient anaesthetic record. If clinical problems arise, the drug can be re-identified by comparison with the patients study number.
The drugs will be provided in syringes labelled "study drug". Study drugs will be administered post induction of anaesthesia by a 30-minute infusion of either ibuprofen or placebo, and a stat push of parecoxib or placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number generator
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 252 with 63 patients per group achieves 84% power at alpha level 0.05 to detect a reduction in pain scores of 2 between treatment groups based on a standard deviation of 2.06 from a similar surgical population (PAINFREE study figures). To allow for withdrawals, the sample size per group will be increased to 70 for a total sample size of 280.
Six pairwise comparisons will be made: Placebo vs. Ibuprofen, Placebo vs. Parecoxib 40mg, Placebo vs. Parecoxib 80mg, Ibuprofen vs. Parecoxib 40mg, Ibuprofen vs. Parecoxib 80mg, Parecoxib 40mg vs. Parecoxib 80mg. An intention to treat analysis will be performed. Descriptive statistics will be median, interquartile range (IQR) and range or mean (standard deviation [SD]) as appropriate. Categorical outcomes will be summarized using frequency distributions. The Chi-square test or Fisher exact test will be used for comparisons of categorical outcomes between groups. Comparison of continuous outcomes between groups will be based on Kruskal-Wallis analysis of variance assuming lack of normality. Duration until first analgesic rescue will be estimated using Kaplan-Meier survival probabilities and log-rank test for group comparisons. P-values of <0.05 will be considered statistically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2013
Actual
30/07/2014
Date of last participant enrolment
Anticipated
Actual
10/07/2019
Date of last data collection
Anticipated
Actual
11/07/2019
Sample size
Target
280
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1675 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 7551 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 288242 0
Hospital
Name [1] 288242 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital
Country [1] 288242 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital
Address
374 Bagot Road
Subiaco WA 6008
Australia
Country
Australia
Secondary sponsor category [1] 286959 0
None
Name [1] 286959 0
Address [1] 286959 0
Country [1] 286959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290146 0
Women and Newborn Health Service Ethics Committee
Ethics committee address [1] 290146 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco WA 6008
Australia
Ethics committee country [1] 290146 0
Australia
Date submitted for ethics approval [1] 290146 0
Approval date [1] 290146 0
16/08/2013
Ethics approval number [1] 290146 0

Summary
Brief summary
This trial will compare three intravenous anti-inflammatory regimens against placebo in women undergoing hysteroscopy and dilatation and curettage (D&C) as a day case surgery. It will compare the effectiveness of pain relief immediately post surgery and during the subsequent 24 hours. It will also compare the incidence and severity of side effects of pain relieving drugs including nausea and itch, and overall quality of recovery from surgery using a well validated questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44174 0
A/Prof Nolan McDonnell
Address 44174 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco WA 6008
Australia
Country 44174 0
Australia
Phone 44174 0
+61893402222
Fax 44174 0
Email 44174 0
[email protected]
Contact person for public queries
Name 44175 0
Nolan McDonnell
Address 44175 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco WA 6008
Australia
Country 44175 0
Australia
Phone 44175 0
+61893402222
Fax 44175 0
Email 44175 0
[email protected]
Contact person for scientific queries
Name 44176 0
Nolan McDonnell
Address 44176 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco WA 6008
Australia
Country 44176 0
Australia
Phone 44176 0
+61893402222
Fax 44176 0
Email 44176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised patient data including demographics, results
When will data be available (start and end dates)?
Subsequent to publication in perpetuity
Available to whom?
Journals or authors of systematic reviews or meta-analyses with appropriate ethics approval and approval from our institution
Available for what types of analyses?
Meta-analyses and systematic reviews
How or where can data be obtained?
On request via principle investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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