Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001629426p
Ethics application status
Not yet submitted
Date submitted
19/11/2016
Date registered
24/11/2016
Date last updated
24/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of transversus abdominis plane (TAP) block vs port site infiltration: pain levels and analgesia requirements in women undergoing gynaecological laparoscopy.
Scientific title
A comparison of transversus abdominis plane (TAP) block and port site infiltration for analgesia in gynaecological laparoscopy.
Secondary ID [1] 290577 0
None
Universal Trial Number (UTN)
U1111-1190-0825
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 301033 0
Condition category
Condition code
Anaesthesiology 300824 300824 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transversus abdominis plane (TAP) regional block using 20ml of 0.75% ropivacaine placed under laparoscopic direct vision by surgeon at end of operation.
Intervention code [1] 296442 0
Treatment: Drugs
Comparator / control treatment
Local anaesthetic infiltration around laparoscopic port sites using up to 20ml of 0.75% ropivacaine, with the exact volume at the discretion of the surgeon.
Control group
Active

Outcomes
Primary outcome [1] 300246 0
Pain as measured by the visual analogue scale.
Timepoint [1] 300246 0
Two hours after arriving in the post-anaesthesia care unit.
Secondary outcome [1] 329490 0
Pain as measured by the visual analogue score 24 hours after arrival in the post-anaesthesia care unit.
Timepoint [1] 329490 0
24 hours after arrival in the post-anaesthesia care unit.
Secondary outcome [2] 329491 0
Amount of fentanyl used in the post-anaesthesia recovery unit measured in micrograms.
Timepoint [2] 329491 0
During stay in the PACU.

Eligibility
Key inclusion criteria
Women undergoing gynaecological laparoscopy over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy or intolerance to study drugs including sulfa drugs, local anaesthetic drugs, morphine, oxycodone or fentanyl.

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)
Sequence is generated by http://sealedenvelope.com
Surgeon visits site and obtains treatment allocation. This with patient's trial number is emailed to principal investigator. Anaesthetist, and all staff assessing outcomes postoperatively are blinded to the manner of local anaesthetic instillation. Surgeon is not blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted block randomization via sealedenvelope.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Unpaired t-test comparing means.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6956 0
Epworth Freemasons - Melbourne
Recruitment hospital [2] 6957 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 6958 0
Cabrini Brighton - Brighton
Recruitment postcode(s) [1] 14647 0
3002 - Melbourne
Recruitment postcode(s) [2] 14648 0
3144 - Malvern
Recruitment postcode(s) [3] 14649 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 295010 0
Self funded/Unfunded
Name [1] 295010 0
Dr Mark Suss
Country [1] 295010 0
Australia
Funding source category [2] 295041 0
Hospital
Name [2] 295041 0
Epworth Healthcare
Country [2] 295041 0
Australia
Primary sponsor type
Individual
Name
Dr Mark Suss
Address
Victoria Parade Anaesthetic Services
Suite 505/100 Victoria Parade
East Melbourne
Victoria 3002
Country
Australia
Secondary sponsor category [1] 293828 0
None
Name [1] 293828 0
none
Address [1] 293828 0
Country [1] 293828 0
Other collaborator category [1] 279315 0
Individual
Name [1] 279315 0
Dr Catarina Ang
Address [1] 279315 0
Royal Women's Hospital
Consulting Address:
315 Wattletree Road
Malvern East
Victoria 3145
Country [1] 279315 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296366 0
Epworth Healthcare HREC
Ethics committee address [1] 296366 0
Mailbox #4
Epworth HealthCare
89 Bridge Road
Richmond VIC 3121
Ethics committee country [1] 296366 0
Australia
Date submitted for ethics approval [1] 296366 0
24/11/2016
Approval date [1] 296366 0
Ethics approval number [1] 296366 0

Summary
Brief summary
Laparoscopic (‘keyhole’) surgery is used to perform many different types of gynaecological surgery. These include diagnosis of reasons why pregnancy has not been possible, diagnosis of abdominal pain, and treatment of endometriosis (which is painful, abnormal tissue in the abdomen (belly). It also includes procedures using a robot to aid surgery, and removal of organs or abnormal growths.

There are several causes of pain after this sort of surgery. One cause of pain is local damage to the wall of the abdomen due to the tubes that run into the abdomen that make keyhole surgery possible. For a long time surgeons have used local anaesthetic in small amounts that is injected into the holes or ‘port sites’ where these tubes are inserted.

More recently a different way of giving local anaesthetic has become popular. This is called the ‘TAP block’ which stands for “transversus abdominis plane” block. The name simply means that it is injected alongside the transversus muscle in the wall of the abdomen. Anaesthetists tend to use an ultrasound probe to take a picture and place this at the right depth, but for surgeons to place it laparoscopically while they operate is also a recognised technique.


This study will investigate whether the infiltration method or TAP method of giving local anaesthetic is more effective by measuring pain on a scale of 1 to 10 just after surgery and 24 hours after surgery. The surgeon will be instructed to perform either the TAP block or infiltration based on the patient’s randomisation. The anaesthetist, recovery staff, and patient will be blinded, so unaware of what the patient has received. The surgeon, who is not blinded, will not be involved in any measurement of pain scores.

Patients undergoing any type of gynaecological keyhole surgery will be accepted.

TAP blocks have been looked at in many trials now. There are some aspects to this trial which would be novel in combination and would add to our knowledge base.

The surgeon would be giving the block. This approach has been used relatively rarely. By doing away with the need to keep the patient asleep while the anaesthetic performs the block and gets set up with an ultrasound machine, the block can be performed with minimal delay to the list.
This is a ‘real-world’ trial which compares two commonly-used techniques, rather than comparing TAP blocks to injection of saline, which means that a convincing result would guide the choice to use one or the other.
This trial is not restricted to some subgroup of gynaecology patient; it would look at a cross-section of any day-case or inpatient laparoscopic gynaecology population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70594 0
Dr Mark Suss
Address 70594 0
Victoria Parade Anaesthetic Services
Suite 505, 100 Victoria Parade
East Melbourne
Victoria 3002
Country 70594 0
Australia
Phone 70594 0
+61390389333
Fax 70594 0
Email 70594 0
marksuss+ctr@gmail.com
Contact person for public queries
Name 70595 0
Dr Mark Suss
Address 70595 0
Victoria Parade Anaesthetic Services
Suite 505, 100 Victoria Parade
East Melbourne
Victoria 3002
Country 70595 0
Australia
Phone 70595 0
+61390389333
Fax 70595 0
Email 70595 0
marksuss+ctr@gmail.com
Contact person for scientific queries
Name 70596 0
Dr Mark Suss
Address 70596 0
Victoria Parade Anaesthetic Services
Suite 505, 100 Victoria Parade
East Melbourne
Victoria 3002
Country 70596 0
Australia
Phone 70596 0
+61390389333
Fax 70596 0
Email 70596 0
marksuss+ctr@gmail.com

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
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