ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001125415

Ethics application status

Approved

Date submitted

30/07/2016

Date registered

18/08/2016

Date last updated

3/09/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Post Operative Pain Management Following Pterygium Surgery

Scientific title

Efficacy of sub-tenons bupivacaine for post-operative pain management following pterygium surgery.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Pain severity following pterygium excision (with free conjunctival graft and glue)

Condition category

Condition code

Eye

Diseases / disorders of the eye

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Single dose Bupivacaine (0.5%) 2.5mls into the subtenon space in an eye undergoing pterygium excision. The anaesthetic is drawn up by the scrub nurse and injected via a subtenons cannula by the surgeon after the pterygium has been removed, but before the graft is secured to the sclera.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Basic salt solution (2.5mls) injected into the subtenons space by the surgeon at the time of pterygium surgery (placebo arm)

Control group

Placebo

Outcomes

Primary outcome [1]

All patients will be asked to complete a questionaire for days 3 post surgery. Ms Hughes will contact patients daily for four days and document the following variables (pain, irritation, light sensitivity) as well as total pain relief consumed. . .

Pain score graded on a continous scale from 1-10.
0 = no pain
10 = severe pain

Patients always receive a drop of topical anaesthetic (tetracaine 1%) immediately prior to surgery. This drop causes a stinging senation/pain in the eye.. As pain is a subjective experience, patients will be asked to quantify their pain following instillation of topical anaesthetic. This information will allow adjustments to be carried out for individual pain tolerance when interpreting pain scores.

Timepoint [1]

Daily assessment of pain for three days postoperatively.

Secondary outcome [1]

Irritation graded as none/mild/moderate/severe

Timepoint [1]

Irritation severity graded daily for three days postoperatively.

Secondary outcome [2]

Light sensitvity as graded as none/mild/moderate/severe

Timepoint [2]

Light sensitivity severity grade daily for three days postoperatively.

Secondary outcome [3]

Ms Hughes will contact patients daily for four days to assess the total amount and type of pain relief consumed each day. The questionnaire also asks patients to self report the type (and time) of pain relief consumed each day based on a list of options ie paracetamol 1g QID/prn, ibuprofen 400mg TDS/prn (with food) and tramadol 50mg QID/prn.

Timepoint [3]

Total pain relief consumed daily for the first three postoperative days.

Eligibility

Key inclusion criteria

Age >18
Primary nasal pterygium excision with conjunctival graft and glue
Understands the risks/benefits of the study
Able to give consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Recurrent pterygium
Multiple pterygiums present in the operated eye
Surgery performed under general anaesthesia
Suture required during surgery

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)

Double blinded RCT

Central randomisation by computer (Office Excel) by an independent party. Allocation plan will be secured in an opaque envelope and opened by the nurses assisting the surgeon. The nurse who will prepare the subtenons syringe depending on which arm the patient is allocated to. The surgeon will administer the intervention.

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

Simple randomisation using a randomisation table created by computer software (Office Excel)

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

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Other studies have recorded pain scores of 5/10 on the day of surgery and scores of 3/10 for the subsequent 3 days. In order to observe a reduction in the amount of pain from 5 to 3 (standard deviation 2) on the day of surgery with an alpha error of 0.05 and study power of 0.8 (Beta = 0.2), we calculated that 16 patients would be required in each arm.
.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/10/2016

Actual

5/10/2016

Date of last participant enrolment

Anticipated

15/09/2017

Actual

30/01/2018

Date of last data collection

Anticipated

15/09/2017

Actual

30/01/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Waikato Hospital

Address [1]

Selwyn Street and Pembroke Street, Hamilton 3204

Country [1]

New Zealand

Funding source category [2]

Hospital

Name [2]

Palmerston North Public Hospital

Address [2]

50 Ruahine St, Roslyn, Palmerston North 4442

Country [2]

New Zealand

Primary sponsor type

Hospital

Name

Waikato Hospital

Address

Selwyn Street and Pembroke Street, Hamilton 3204

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Palmerston North Hospital

Address [1]

50 Ruahine St, Roslyn, Palmerston North 4442

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

26/09/2016

Ethics approval number [1]

16/STH/144

Summary

Brief summary

A pterygium is a noncancerous growth on the front surface of the eye (cornea) which can cause redness, irritation and distortion in vision.  The aim of surgery is to restore the normal curvature of front of the eye by peeling the pterygium off the cornea. This is done under local anaesthesia, in the form of eye drops and an anaesthetic injection into the pterygium. The medicine commonly used for injection are lidocaine or bupivacaine, the latter has a slightly greater duration of effect. The anaesthetic wears off shortly after the surgery after which the eye becomes uncomfortable, especially for the first 24 hours following surgery. This is because the cornea is more sensitive than any other structure in the body and the takes 3-7 days to heal. Unfortunately most conventional oral pain relief medicines do not effectively reduce eye pain. 
							          
There are other ways of numbing the eye including a subtenons block where an anaesthetic medicine (mentioned above) is injected around the eye at the time of surgery. This is easily done once the pterygium has been removed as the subtenons space becomes accessible.  This type of anaesthetic not only numbs the eye but temporally impairs ocular motility, causes drooping of the  upper lid and can impair vision for up to 8 hours. The latter is not an issue as a pad covers the eye for the first 24hrs after surgery. This type of regional anaesthesia is very safe and is routinely performed for patients undergoing intraocular procedures such as cataract surgery. Anecdotal evidence suggests this mode of anaesthesia may provide better postoperative pain control for patients undergoing pterygium surgery. The aim of our study is to determine wheather a subtenons block given at the time of surgery, in addition to topical and injected anaesthesia,  provides better short term post-operative pain control for patients undergoing pterygium surgery compared to traditional methods of anaesthesia.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/371159-HDEC Letter 16STH144 Prov App FULL Application.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Riyaz Bhikoo

Address

Palmerston North Hospital
50 Ruahine St, Roslyn, Palmerston North 4442

Country

New Zealand

Phone

+64 6-356 9169

Fax

riyazbhikoo@gmail.com

Contact person for public queries

Name

Riyaz Bhikoo

Address

Palmerston North Hospital
50 Ruahine St, Roslyn, Palmerston North 4442

Country

New Zealand

Phone

+64 6-356 9169

Fax

riyazbhikoo@gmail.com

Contact person for scientific queries

Name

Riyaz Bhikoo

Address

Palmerston North Hospital
50 Ruahine St, Roslyn, Palmerston North 4442

Country

New Zealand

Phone

+64 6-356 9169

Fax

riyazbhikoo@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

Source	Title	Year of Publication	DOI
Embase	Subtenon Bupivacaine for Postoperative Pain in Patients Undergoing Pterygium Excision: A Double-Blinded Randomized Control Trial.	2019	https://dx.doi.org/10.1097/ICO.0000000000001973

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

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Documents added manually

Documents added automatically