Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000785202
Ethics application status
Approved
Date submitted
2/09/2009
Date registered
9/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pre-peritoneal local anaesthetic to decrease pain in hernia repairs study
Scientific title
A randomised controlled study evaluating the effectiveness of local anaesthetic into the pre-peritoneal space in controlling post operative pain in laparoscopic inguinal and femoral hernia repairs.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal and femoral hernias 243617 0
Condition category
Condition code
Surgery 239914 239914 0 0
Surgical techniques
Oral and Gastrointestinal 239958 239958 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20ml of local anaesthetic (Bupivicaine Hydrochloride 0.25% with adrenaline) vs Placebo (0.9% Sodium Chloride) injected into the pre-peritoneal space during the surgery.
Intervention code [1] 241205 0
Treatment: Drugs
Comparator / control treatment
20ml of local anaesthetic (Bupivicaine Hydrochloride 0.25% with adrenaline) vs Placebo (0.9% Sodium Chloride) injected into the pre-peritoneal space during the surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 240696 0
Post-operative pain

Post-operative pain will be assessed using the visual analogue scale.
Timepoint [1] 240696 0
Pain scores will be assessed before surgery, day 1, 7, 14 and 6 weeks after surgery.
Secondary outcome [1] 257344 0
Assessment of post operative pain and other surgical complications (urinary retention, femoral nerve block, seroma, recurrence, wound infection, mesh rejection and overnight stay). These will be assessed by physical examination and phone assessments.
Timepoint [1] 257344 0
Symptom review will be assessed day 1, 7, 14 and 6 weeks after surgery.

Eligibility
Key inclusion criteria
Patients with femoral and inguinal hernias that are suitable for laparoscopic surgical repair aged between 18 and 80 years, fit for day surgery and able to consent to the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have an allergy to marcain with adrenaline
Patients with whom the anaesthetist deems marcain with adrenaline is unsuitable.
Patients unavailable for follow-up
Patients eligible for the Laparoscopic versus Open Inguinal Hernia Repair Study currently recruiting at Waitemata District Health Board

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)
Patients will be randomised in the operating room. The anaesthetist will be given the randomisation envelope. This will describe whether the patient receives local anaesthetic or placebo (0.9% sodium chloride) into the pre-peritoneal space. He/she will check the vial of either marcain 0.25% with adrenaline or 0.9% sodium chloride (name and appearance of the randomised solution, volume to be administered and the expiry date) with the circulating nurse. The circulating nurse will give the solution to the scrub nurse to draw up. This will occur while the surgeon is scrubbing his hands in the scrub bay (not in the operating room) prior to the start of the operation. The surgeon will be able to administer the local or placebo after verifying that it has been checked by the anaesthetist and the circulating nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple ranodmisation done by the statistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1969 0
New Zealand
State/province [1] 1969 0
Auckland

Funding & Sponsors
Funding source category [1] 237563 0
Hospital
Name [1] 237563 0
Waitemata District Health Board
Country [1] 237563 0
New Zealand
Primary sponsor type
Individual
Name
Mr Michael Hulme-Moir
Address
Dept of Surgery
North Shore Hospital
Waitemata District Health Board
Private Bag 93 503
Takapuna
Auckland 0740
Country
New Zealand
Secondary sponsor category [1] 237039 0
Individual
Name [1] 237039 0
Mr Michael Hulme-Moir
Address [1] 237039 0
Waitemata Specialist Centre
13-15 Shea Terrace
Takapuna
Auckland 0740
Country [1] 237039 0
New Zealand
Other collaborator category [1] 834 0
Hospital
Name [1] 834 0
Southern Cross Hospital
Address [1] 834 0
Southern Cross Hospital North Harbour
232 Wairau Road
Glenfield
Auckland 0627
Country [1] 834 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243694 0
Northern X Regional Ethics Committee
Ethics committee address [1] 243694 0
3rd Floor, Unisys Building
650 Great South Road, Penrose
Private Bag 92 522, Wellesley St
Auckland 1061
Ethics committee country [1] 243694 0
New Zealand
Date submitted for ethics approval [1] 243694 0
22/04/2009
Approval date [1] 243694 0
02/06/2009
Ethics approval number [1] 243694 0
NTX/09/05/039

Summary
Brief summary
The aims of this study are to assess post operative pain and other surgical complications on elective laparoscopic hernia repair patients following the injection of local anaesthetic into the pre-peritoneal space.

This study will enrol patients aged 18 – 80 years of age who are suitable for day surgical repair of their hernias at Waitemata District Health Board and Waitemata Specialist Centre (surgery at Southern Cross Hospital North Harbour).

Participants will be randomised to receive 20mls of local anaesthetic or 20mls of normal saline injected into the pre-peritoneal space. They will be followed up by phone at 2 hours after surgery, 1, 7 and 14 days after surgery. They will be seen in the outpatients clinic at 6 weeks after the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30106 0
Address 30106 0
Country 30106 0
Phone 30106 0
Fax 30106 0
Email 30106 0
Contact person for public queries
Name 13353 0
Lauren Porten
Address 13353 0
Dept of Surgery, North Shore Hospital
Private Bag 93 503
Takapuna
Auckland 0740
Country 13353 0
New Zealand
Phone 13353 0
+64 9 486 8920 extn 7125
Fax 13353 0
+64 9 488 4664
Email 13353 0
lauren.porten@waitematadhb.govt.nz
Contact person for scientific queries
Name 4281 0
Mr Michael Hulme-Moir
Address 4281 0
Dept of Surgery, North Shore Hospital
Private Bag 93 503
Takapuna
Auckland 0740
Country 4281 0
New Zealand
Phone 4281 0
+64 9 486 8920 extn 2459
Fax 4281 0
+64 9 486 4664
Email 4281 0
michael.hulme-moir@waitematadhb.govt.nz

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.