Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000126819
Ethics application status
Approved
Date submitted
11/01/2012
Date registered
25/01/2012
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Naropin vs. Marcaine in Pudendal Nerve Block in Open Haemorroidectomy
Scientific title
Comparing the effectiveness between the two local anaesthetic agents. Naropin vs Marcaine in Pudendal Nerve Block in Open Haemorroidectomy
Secondary ID [1] 279719 0
"None"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open haemorrhoidectomy 285546 0
Condition category
Condition code
Surgery 285739 285739 0 0
Surgical techniques
Anaesthesiology 285747 285747 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Naropin versus marcaine in controlling postoperative pain
after open haemorrhoidectomy.
One group recieves 20 mls of Naropin 0.75% ( 150 mgs)administered as a local injection near the course of the pudendal nerve. 10 mls will be admisnistered on each side.
The other group will receive 20 mls of Marcaine 0.5%( 100 mgs) admisnistered as before.
In regards to the surgery itself; it is open haemorroidectomy, done under GA. patient is positioned in lithotomy position. LA is administred as described before. Haemorroids are excised. Haemostasis secured . All patents will be discharged home with oral metronidazole 400mg TDS for 5 days and oral endone tablets of 5 mg for pain as required by patient.
Intervention code [1] 284011 0
Treatment: Drugs
Comparator / control treatment
One group recieves 20 mls of Naropin 0.75% ( 150 mgs)administered as a local injection near the course of the pudendal nerve. 10 mls will be admisnistered on each side.
The other group will receive 20 mls of Marcaine 0.5%( 100 mgs) admisnistered as before.
Control group
Dose comparison

Outcomes
Primary outcome [1] 286264 0
To compare the effectivness between two local anaesthetic agents in performing Pudendal nerve block
Timepoint [1] 286264 0
Assessed daily for the first 7 days then at a 2 weeks.
Assessments will be a preoperative questionaire and postoperative questionaire regarding expected level of pain and postoperative pain score and use of oral analgesics.
Secondary outcome [1] 295468 0
Evaluate the amount of oral analgesics used and to compare that to the type of the local anaesthetic used.
Timepoint [1] 295468 0
Assessed daily for the first 7 days then at a 2 weeks.
Assessments will be a preoperative questionaire and postoperative questionaire regarding expected level of pain and postoperative pain score and use of oral analgesics.
Secondary outcome [2] 295488 0
Participation of Sitz Bath ( Salt bath) manoeuvre in relief of pain. This is not compulsory the use of one will just be captured.
Timepoint [2] 295488 0
Assessed daily for the first 7 days then at a 2 weeks.
Assessments will be a preoperative questionaire and postoperative questionaire regarding expected level of pain and postoperative pain score and use of oral analgesics.

Eligibility
Key inclusion criteria
All adult participants who have haemorrhoids and require surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Allergic to either local anaesthetic agents or refuse to participate in the study.
Pregnancy: no unnecessary general anaesthetic
Children/young people: can't consent to study, and also their prticipation in answering the questionnaire maybe subjectively inadequate.
people highly dependent on medical care: inadequate consent and unable to participate in the questionnaire.

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)
Group 1
Group name for participants in this group: 0.5% marcaine
Expected number of participants in this group: 30.
Group 2
Group name for participants in this group: 0.75% Naropin
Expected number of participants in this group: 30

Allocation for all will be done post consent by taking the next sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Single blinded study, randomisation in block to ensure equal number of subjects in each arm. The assessor/conducting interview and phone calls is blind to which local anaesthetic is used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study involves double blinded randomised controlled trial, the surgeon is blinded to which local anaesthetic is
used and the assessor is also blinded to which agent has been used. Pudendal nerve block is performed by the
colorectal surgeon prior to preceeding to perform open haemorrhoidectomy
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Investigator changed jobs
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284491 0
Self funded/Unfunded
Name [1] 284491 0
Country [1] 284491 0
Primary sponsor type
Hospital
Name
Gold Coast Hospital
Address
108 Nerang Street
SOUTHPORT, QLD 4214
Country
Australia
Secondary sponsor category [1] 283417 0
None
Name [1] 283417 0
Address [1] 283417 0
Country [1] 283417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286473 0
Gold Coast Health Services District Ethics Committee
Ethics committee address [1] 286473 0
108 Nerang Street, SOUTHPORT, QLD 4215
Ethics committee country [1] 286473 0
Australia
Date submitted for ethics approval [1] 286473 0
14/09/2011
Approval date [1] 286473 0
14/10/2011
Ethics approval number [1] 286473 0
11/QGC/127

Summary
Brief summary
The study involves double blinded randomised controlled trial, the surgeon is blinded to which local anaesthetic is
used and the assessor is also blinded to which agent has been used. Pudendal nerve block is performed by the
colorectal surgeon prior to preceeding to perform open haemorrhoidectomy
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33620 0
Dr Dr mohammad Alassaf
Address 33620 0
GCUH
1 HOSPITAL blvd, southport,
qld 4215
Country 33620 0
Australia
Phone 33620 0
0756875678
Fax 33620 0
Email 33620 0
[email protected]
Contact person for public queries
Name 16867 0
Dr Dr mohammad Alassaf
Address 16867 0
Gold Coast Hospital
108 Nerang Street
SOUTHPORT
QLD 4215
Country 16867 0
Australia
Phone 16867 0
0061-7-55198211
Fax 16867 0
Email 16867 0
[email protected]
Contact person for scientific queries
Name 7795 0
Dr Dr mohammad Alassaf
Address 7795 0
Gold Coast Hospital
108 Nerang Street
SOUTHPORT
QLD 4215
Country 7795 0
Australia
Phone 7795 0
0061-7-55198211
Fax 7795 0
Email 7795 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.