ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000242921

Ethics application status

Approved

Date submitted

7/02/2020

Date registered

26/02/2020

Date last updated

26/02/2020

Date data sharing statement initially provided

26/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Superior Hypogastric Nerve Block in Minimally-invasive Gynaecology: a Randomised Controlled Trial (Hypoplex Study)

Scientific title

Superior Hypogastric Plexus Nerve Block in Minimally-invasive Gynaecology and it's effect on Post-operative Opiate requirements: a Randomised Controlled Trial (Hypoplex Study)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1247-8778

Trial acronym

Hypoplex Study

Linked study record

nil

Health condition

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

Post operative pain

Condition category

Condition code

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

10ml of 0.75% Ropivacaine (local anaesthetic) injected retroperitoneally within the presacral space targeting the superior hypogastric plexus.

Injection provided at the end of minimally invasive gynaecology surgery using laparoscopic guidance

Stratified randomisation with four patient arms
Arm 1- Laparoscopic Hysterectomy
Arm 2- Laparoscopic Myomectomy
Arm 3- Robotic-assisted Laparoscopic Hysterectomy
Arm 4- Robotic-assisted Laparoscopic Myomectomy

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

1:1 randomisation protocol (nerve block vs control)
Patient-blinded only

Control group receives no nerve-block at the end of the procedure

Control group

Active

Outcomes

Primary outcome [1]

Total opioid use in first 24 hours after surgery (from patient-controlled analgesia pump)

Timepoint [1]

first 24 hours post surgery

Secondary outcome [1]

Visual analogue scale (VAS) pain scores
Scale runs from 1 to 10

Timepoint [1]

First 24 hours after surgery.
At time points 1, 2, 4, 6, 12 and 24 hours post surgery

Eligibility

Key inclusion criteria

Age 18 years and over
Able to give informed consent
Undergoing laparoscopic hysterectomy, laparoscopic myomectomy, robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Known Malignancy
Liver failure or coagulopathy
Known hypersensitivity or allergy to local anaesthetic
Surgeon/ anaesthetic concerns on ability for patient to use patient-controlled opiate analgesia post-operative
Regular opioid use

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation performed by medical statistician external to trial
Randomisation outcomes provided in sealed opaque envelopes to surgeon and principal investigator
Envelope opened at the end of the surgery- determining which arm the patient will be in

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation in groups of 16 for the four stratified groups.
Randomisation performed by computer software by medical statistician

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

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Study powered to detect a 30% reduction in opioid requirements for the group randomised to receive the nerve block.
Power level set at 80%.

Prior audit of 20 patients' use of opioid medication after the same surgeries (without the nerve block) used to establish mean and standard deviation of opioid use in patients.
G-Power software used to perform power calculations.

Total sample size of 50 required to study for a 30% reduction in opioid use. At 1:1 randomisation this equates to 25 patients in each arm

Primary outcome of total opioid use over 24h will be analysed using Mann-Whitney U analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/03/2020

Actual

Date of last participant enrolment

Anticipated

11/05/2020

Actual

Date of last data collection

Anticipated

15/06/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Private Hospital - Kogarah

Recruitment postcode(s) [1]

2217 - Kogarah

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Sydney Women's Endosurgery Centre

Address [1]

Sydney Women's Endosurgery Centre
Suite 2, Level 1
37 Gloucester Road
Hurstville 2220
Sydney, NSW

Country [1]

Australia

Primary sponsor type

Individual

Name

Praveen De Silva

Address

Sydney Women's Endosurgery Centre
Suite 2, Level 1
37 Gloucester Road
Hurstville 2220
Sydney, NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District HREC

Ethics committee address [1]

G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/09/2019

Approval date [1]

09/12/2019

Ethics approval number [1]

2019/ETH00634

Summary

Brief summary

Minimally invasive gynaecology (MIG) requires a high level of pain medication both during the operation and after the operation. This is from the pain elicited during surgical skin incision, gas used in MIG and cutting of tissue and organs. Pain relief after surgery still has a high reliance on opioid medication. In opioid-naïve patients even small doses can lead to poor side effects including nausea and vomiting, slowing of gut transit and difficulty with breathing.

A nerve block to the superior hypogastric nerves has been studied previously through observational trials. First in patients with pelvic cancers and more recently for patients after surgery. It is not a difficult nerve block to teach to laparoscopic surgeons. Ropivacaine which is used for the nerve block is a well-studied medication and approved for use by the TGA in Australia. It is also cheap. We plan to study the effect this nerve block as it could be useful adjunct to post-operative pain relief in the future.

This is a single-centre, patient-blinded randomised controlled trial. Patients undergoing minimally invasive gynaecological surgery will be randomised to receive a superior hypogastric nerve block with Ropivacaine at the end of their surgery versus no nerve block. The primary outcome to be studied will be total opioid use in the first 24 hours after surgery. Our secondary outcome is pain scores at regular intervals in the first 24 hours. This will be performed using a visual analogue scale from 1 to 10.

Our hypothesis is that patients receiving a nerve block will use 30% less opioid over the first 24 hours compared to patients not receiving one. 

We also predict patients receiving the nerve block will have lower pain scores.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Praveen De Silva

Address

Sydney Women’s Endosurgery Centre
Suite 2, Level 1
37 Gloucester Rd
Hurstville NSW 2220

Country

Australia

Phone

+61 2 9553 6500

Fax

prav.desilva@gmail.com

Contact person for public queries

Name

Praveen De Silva

Address

Sydney Women’s Endosurgery Centre
Suite 2, Level 1
37 Gloucester Rd
Hurstville NSW 2220

Country

Australia

Phone

+61 2 9553 6500

Fax

prav.desilva@gmail.com

Contact person for scientific queries

Name

Praveen De Silva

Address

Sydney Women’s Endosurgery Centre
Suite 2, Level 1
37 Gloucester Rd
Hurstville NSW 2220

Country

Australia

Phone

+61 2 9553 6500

Fax

prav.desilva@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Have not requested ethics permission for this at this stage

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		block appears to be favourable in reducing opioid ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Superior Hypogastric Plexus Nerve Block in Minimally Invasive Gynecology: A Randomized Controlled Trial.	2022	https://dx.doi.org/10.1016/j.jmig.2021.06.017

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically