ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1190-0825

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postoperative pain

Condition category

Condition code

Anaesthesiology

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]

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]

Pain as measured by the visual analogue scale.

Timepoint [1]

Two hours after arriving in the post-anaesthesia care unit.

Secondary outcome [1]

Pain as measured by the visual analogue score 24 hours after arrival in the post-anaesthesia care unit.

Timepoint [1]

24 hours after arrival in the post-anaesthesia care unit.

Secondary outcome [2]

Amount of fentanyl used in the post-anaesthesia recovery unit measured in micrograms.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Freemasons - Melbourne

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [3]

Cabrini Brighton - Brighton

Recruitment postcode(s) [1]

3002 - Melbourne

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

3186 - Brighton

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Mark Suss

Address [1]

Victoria Parade Anaesthetic Service
Suite 505/100 Victoria Parade
East Melbourne
VIctoria 3002

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Epworth Healthcare

Address [2]

320 Victoria Parade, East Melbourne VIC 3002

Country [2]

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]

None

Name [1]

none

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Catarina Ang

Address [1]

Royal Women's Hospital
Consulting Address:
315 Wattletree Road
Malvern East
Victoria 3145

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Epworth Healthcare HREC

Ethics committee address [1]

Mailbox #4 
Epworth HealthCare
89 Bridge Road
Richmond VIC 3121

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/11/2016

Approval date [1]

Ethics approval number [1]

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

Dr Mark Suss

Address

Victoria Parade Anaesthetic Services
Suite 505, 100 Victoria Parade
East Melbourne
Victoria 3002

Country

Australia

Phone

+61390389333

Fax

marksuss+ctr@gmail.com

Contact person for public queries

Name

Mark Suss

Address

Victoria Parade Anaesthetic Services
Suite 505, 100 Victoria Parade
East Melbourne
Victoria 3002

Country

Australia

Phone

+61390389333

Fax

marksuss+ctr@gmail.com

Contact person for scientific queries

Name

Mark Suss

Address

Victoria Parade Anaesthetic Services
Suite 505, 100 Victoria Parade
East Melbourne
Victoria 3002

Country

Australia

Phone

+61390389333

Fax

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

No additional documents have been identified.

Trial Review

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