Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001055998p
Ethics application status
Submitted, not yet approved
Date submitted
19/08/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Intraperitoneal instillation of Ropivacaine at gynaecological laparoscopy: a randomised control trial
Scientific title
Effect of intraperitoneal instillation of Ropivacaine at gynaecological laparoscopy on post-operative pain scores: a randomised control trial.
Secondary ID [1] 302083 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative pain 318691 0
hysterectomy
 318692 0
endometriosis
 318693 0
Condition category
Condition code
Surgery 316703 316703 0 0
Other surgery
Anaesthesiology 316704 316704 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised control trial with two arms, intervention and placebo. The intervention is instillation of a single dose of 2.5mg/kg of Ropivacaine into the pelvis at the completion of laparoscopic hysterectomy or three compartment endometriosis resection. The maximum dose administered to a patient will be 300mg and the fluid will be instilled into the pelvis via a laparoscopic port. The placebo arm will receive a matched volume per kg of normal saline into the pelvic. The intervention/placebo will be administered by the research team.
Intervention code [1] 318381 0
Treatment: Drugs
Comparator / control treatment
The control group will receive a normal saline placebo instilled into the pelvis at the completion of surgery. The weight based volume of 0.5% Ropivacaine will be used to determine the volume of study drug or placebo to be instilled according to the patients blinded study allocation.
Control group
Placebo

Outcomes
Primary outcome [1] 324837 0
VAS pain score.
Timepoint [1] 324837 0
at 1, 4, 8 and 24 hours post operatively.
Secondary outcome [1] 385896 0
Consumption of opioid analgesia which will be assessed via the return of patient information forms and assessment of data within the medical record.
Timepoint [1] 385896 0
1, 4, 8, 24 and 72 hours post-operatively.
Secondary outcome [2] 385897 0
Time to hospital discharge which will be determined from the time of surgery, to the time that the patient is discharged, as will be assessed from data linked to the medical record.
Timepoint [2] 385897 0
The timepoint will be from the time of completion of surgery to the time in hours to discharge from that same admission from hospital.

Eligibility
Key inclusion criteria
Age over 18.
Surgery for - laparoscopic hysterectomy or resection of endometriosis of sufficient volume to result in 3 x compartment resection.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe liver dysfunction
Severe kidney dysfunction
Allergy to Ropivacaine
Pre-existing pain syndrome with daily opioid use of > 3 months duration.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Efficacy
Statistical methods / analysis
96 patients required to show a 10% reduction in VAS score. Due to the inherent difficulties in diagnosing the extent of endometriosis pre surgery, we will recruit an additional 30% to account for loss to following and exclusions after commencing surgery.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17283 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 17284 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 31003 0
4814 - Douglas
Recruitment postcode(s) [2] 31004 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 306505 0
Hospital
Name [1] 306505 0
Townsville University Hospital Study, Education and Research Trust Account (SERTA)
Country [1] 306505 0
Australia
Primary sponsor type
Individual
Name
Vanessa Lusink
Address
Townsville University Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country
Australia
Secondary sponsor category [1] 307031 0
None
Name [1] 307031 0
None
Address [1] 307031 0
Country [1] 307031 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306707 0
Townsville University Hospital Human Research Ethics Committee
Ethics committee address [1] 306707 0
Townsville Institute for Health Research and Innovation (TIHRI)
IMB 101, Level 2, Townsville University Hospital,
100 Angus Smith Drive, Douglas, QLD 4814
Ethics committee country [1] 306707 0
Australia
Date submitted for ethics approval [1] 306707 0
27/07/2020
Approval date [1] 306707 0
Ethics approval number [1] 306707 0

Summary
Brief summary
Pain after surgery can impact your recovery and there has been a lot of research into what we can do to improve your pain. After a laparoscopy for a hysterectomy or endometriosis, you would normally have regular paracetamol and an anti-inflammatory called diclofenac, and some opioid medication called oxycodone for when your pain is particularly bad. We are conducting a trial to determine whether placing some local anaesthetic in the pelvis at the end of your laparoscopic hysterectomy or excision of endometriosis can improve your pain in the first 24 hours after surgery, in addition to the standard medications that you would use for pain.

Approximately 100 women will be involved in the study. You will be randomly allocated to either receiving the local anaesthetic, or receiving a placebo (something that looks exactly like the local anaesthetic but doesn’t have any medicine in it). Neither we, as your doctors, or you will know which allocation you receive, and we cannot decide which allocation you receive if you agree to take part in the study.

After your surgery, we will ask you to tell us about your pain using what is called a ‘visual analogue scale’ at 1, 4, 8 and 24 hrs postoperative. You will need to fill in a paper questionnaire at home. We will also ask you to record how much pain relief you need during the first 8, 24 and 72 hrs. This form can either be emailed or posted back to us via the envelope provided.
A member of the research team will call you at 72 hrs and 2 weeks postoperative to evaluate for any complications.

We will be conducting the study at the Townsville University Hospital and the Mater Hospital in Pimlico.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104742 0
Dr Vanessa Lusink
Address 104742 0
Townsville University Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 104742 0
Australia
Phone 104742 0
+61 7 4433 1111
Fax 104742 0
Email 104742 0
[email protected]
Contact person for public queries
Name 104743 0
Dr Vanessa Lusink
Address 104743 0
Townsville University Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 104743 0
Australia
Phone 104743 0
+61 7 4433 1111
Fax 104743 0
Email 104743 0
[email protected]
Contact person for scientific queries
Name 104744 0
Dr Vanessa Lusink
Address 104744 0
Townsville University Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 104744 0
Australia
Phone 104744 0
+61 7 4433 1111
Fax 104744 0
Email 104744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This would contravene ethics approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.