Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000128291
Ethics application status
Approved
Date submitted
2/11/2008
Date registered
23/02/2009
Date last updated
4/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised double blind placebo controlled trial on the effect of intraperitoneal ropivacaine on postoperative pain and recovery after diagnostic laparoscopy and hysteroscopy.
Scientific title
Randomised double blind placebo controlled trial on the effect of intraperitoneal ropivacaine on postoperative pain and recovery after day case gynaecological diagnostic laparoscopy and hysteroscopy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain following day case gynaecological diagnostic laparoscopy and hysteroscopy. 3905 0
Postoperative nausea and vomiting following day case gynaecological diagnostic laparoscopy and hysteroscopy 3906 0
Postoperative recovery following day case gynaecological diagnostic laparoscopy and hysterocopy. 3907 0
Condition category
Condition code
Anaesthesiology 4105 4105 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is using the local anaesthetic, ropivacaine, intraperitoneally, at the end of the diagnostic hysteroscopy and laparoscopy. The dose used is 20mls of 0.25% (100mg) of ropivacaine. It will take less than two minutes to administer. The intervention treatment will only be administered once.
Intervention code [1] 3632 0
Treatment: Drugs
Comparator / control treatment
The control is 20mls of normal saline to be administered intraperitoneally at the end of the diagnostic hysteroscopy and laparoscopy. It will take less than two minutes to administer. The control treatment will only be administered once.
Control group
Placebo

Outcomes
Primary outcome [1] 4997 0
Amount of analgesia used postoperatively as indicated from hospital records.
Timepoint [1] 4997 0
30min, 60min, 120min, 240min after return to the recovery room.
Secondary outcome [1] 8439 0
Pain score which will be assessed by asking the participant to rate their pain on a visual analogue score on a zero to ten scale line.
Timepoint [1] 8439 0
30 min, 60min, 120min, 240min and 8 hours after return to the recovery room.
Secondary outcome [2] 8665 0
Postoperative recovery generally, measured by how quickly the patient achieves certain milestones - which are - time to first sit up, time to first eating, and time to discharge.
Timepoint [2] 8665 0
Time to first sit up, time to first eating and time to discharge. These will be measured every 5 minutes in the recovery room and then every 15 minutes once the patient has moved to the waiting room.

Eligibility
Key inclusion criteria
Two port diagnostic laparoscopy and hysteroscopy for any gynaecological reason, age 18-50 years.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age <18 years or >50 years,
- non-English speaking
- weight <50kg
- patient refusal
- operative laparoscopy, laparoscopic sterilization
- pregnancy
- 3rd port required intraoperatively
- use of regular narcotic analgesia for pain preoperatively
- contraindications or allergies to any drugs used in the study (including renal disease, diabetes, Non-Steroidal Anti Inflammatory Drug (NSAID) sensitive asthma)

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by number system, using a randomisation table from a statistical book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
1/12/2014
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1241 0
3977

Funding & Sponsors
Funding source category [1] 4096 0
Hospital
Name [1] 4096 0
Monash Medical Centre
Country [1] 4096 0
Australia
Primary sponsor type
Individual
Name
Dr Natasha Frawley
Address
Monash Medical Centre, Clayton Rd, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 3689 0
Individual
Name [1] 3689 0
Professor Beverley Vollenhoven
Address [1] 3689 0
Head of Gynaecology Department, Monash Medical Centre, Clayton Rd, Clayton, VIC, 3168
Country [1] 3689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6167 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 6167 0
Research Support Unit, Level 4 Main block, Monash Medical Centre, Clayton Rd, Clayton, VIC, 3168
Ethics committee country [1] 6167 0
Australia
Date submitted for ethics approval [1] 6167 0
15/12/2008
Approval date [1] 6167 0
01/04/2009
Ethics approval number [1] 6167 0

Summary
Brief summary
BRIEF SUMMARY:
Laparoscopy and hysteroscopy is a common day case gynaecological procedure. This operation involves keyhole surgery, inserting a small telescope-like device or fibreoptic lens into the abdomen via a 10mm port. This enables direct visualisation of inside the abdomen. There is also one other cut on the abdomen of 5mm, where a thin metal probe is inserted. Finally, a second fibreoptic device, is inserted inside the womb via the vagina and cervix, and the inside of the womb is visualised. A scraping of the womb tissue is taken and sent to the pathology laboratory to be analysed under a microscope. Patients usually go home the same day, unless there have been complications.

Pain relief for this procedure has not been studied in any recent large trials. Current pain management involves use of pain relief tablets after the operation, and intravenous analgesics during the operation, including ropivacaine, depending on the anaesthetist.

We aim to evaluate the use of intraperitoneal Ropivacaine. This is a local anaesthetic medication that can be squirted inside the abdomen at the areas that have been manipulated including the womb and fallopian tubes and injected at port sites, which are the two small incisions on the abdomen.

HYPOTHESIS:
We hypothesise that the use of ropivacaine at the end of the procedure will reduce post operative pain and hasten recovery after a diagnostic laparoscopy and hysteroscopy.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 29085 0
Address 29085 0
Country 29085 0
Phone 29085 0
Fax 29085 0
Email 29085 0
Contact person for public queries
Name 12242 0
Dr Natasha Frawley
Address 12242 0
Department of Obstetrics and Gynaecology, Monash Medical Centre, Clayton Rd, Clayton, VIC, 3168
Or:
Department of Obstetrics and Gynaecology, Box Hill Hospital, Nelson Rd, Box Hill, VIC, 3128
Country 12242 0
Australia
Phone 12242 0
+61 3 9895 3333
Fax 12242 0
Email 12242 0
[email protected]
Contact person for scientific queries
Name 3170 0
Dr Natasha Frawley
Address 3170 0
Department of Obstetrics and Gynaecology, Monash Medical Centre, Clayton Rd, Clayton, VIC, 3168
Or:
Department of Obstetrics and Gynaecology, Box Hill Hospital, Nelson Rd, Box Hill, VIC, 3128
Country 3170 0
Australia
Phone 3170 0
+61 3 9895 3333
Fax 3170 0
Email 3170 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.