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Trial registered on ANZCTR


Registration number
ACTRN12613001159741
Ethics application status
Approved
Date submitted
2/10/2013
Date registered
18/10/2013
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Sprayed Peritoneal Regional Analgesia in Appendicectomy trial - SPRAY trial
Scientific title
In children undergoing laparoscopic appendicectomy for acute appendicitis, does local anaesthetic sprayed onto the peritoneum, compared to saline, reduce post-operative pain.
Secondary ID [1] 283341 0
Nil
Universal Trial Number (UTN)
U1111-1148-7094
Trial acronym
SPRAY trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute appendicitis 290235 0
Condition category
Condition code
Surgery 290627 290627 0 0
Surgical techniques
Anaesthesiology 290709 290709 0 0
Anaesthetics
Oral and Gastrointestinal 290710 290710 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
Peritoneal spray of local anaesthetic, bupivacaine, at a concentration of 0.125%, will be sprayed only the peritoneum of the right iliac fossa and pelvis during laparoscopic surgery for suspected appendicitis.
Intervention code [1] 288064 0
Treatment: Drugs
Comparator / control treatment
Peritoneal spray of normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 290640 0
Global pain scores using the Revised Faces Pain Scale (FPS-r), and a novel pain location tool developed by our unit (the Location and Level of Intensity of Postoperative Pain Score - Lolipops).
Timepoint [1] 290640 0
Post-operative hours 0-3, 3-6, 6-12, 12-18 and 18-24.
Secondary outcome [1] 304962 0
Morphine equivalent daily dose
Timepoint [1] 304962 0
24 hours
Secondary outcome [2] 304963 0
Proportion of patients who required opiate analgesia
Timepoint [2] 304963 0
24 hours
Secondary outcome [3] 304964 0
Length of hospital stay
Timepoint [3] 304964 0
30 days

Eligibility
Key inclusion criteria
Acute appendicitis
Children aged 8 years and older
Minimum age
8 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Developmental delay, neuro-muscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness.
Unable to speak and read English
Partially sighted or blind
Presence of any abdominal prostheses such as a gastrostomy or ventriculo-peritoneal shunt
Allergy to bupivacaine
Consent not obtained from both the participating child and a parent or legal guardian

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)
Children will be enrolled by surgical staff on presentation with acute appendicitis. Allocation will be by sealed opaque envelopes. Two theatre nurses will be aware of the allocation in order to prepare the intervention solution, but will not divulge the allocation to any other staff members or investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated using an on-line random number generator (random.org) by a research assistant not involved in any other aspect of the trial.
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Parametric or nonparametric tests (according to normality of data) comparing two groups.
A sample size calculation was based on pain score data from a previous study on pain after appendicectomy. To obtain a 30% (3 points on a 0-10 pain scale) reduction in pain, with alpha 0.05 and 1-beta 0.9, 174 participants will be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2014
Actual
21/05/2014
Date of last participant enrolment
Anticipated
21/05/2015
Actual
9/03/2015
Date of last data collection
Anticipated
Actual
20/04/2015
Sample size
Target
174
Accrual to date
Final
175
Recruitment outside Australia
Country [1] 5457 0
New Zealand
State/province [1] 5457 0

Funding & Sponsors
Funding source category [1] 288073 0
Charities/Societies/Foundations
Name [1] 288073 0
A+ Trust
Country [1] 288073 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland Department of Surgery
Address
Department of Surgery
Faculty of Medicine and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country
New Zealand
Secondary sponsor category [1] 286795 0
None
Name [1] 286795 0
Address [1] 286795 0
Country [1] 286795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290000 0
Health and Disability Ethics Committee
Ethics committee address [1] 290000 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 290000 0
New Zealand
Date submitted for ethics approval [1] 290000 0
02/10/2013
Approval date [1] 290000 0
10/02/2014
Ethics approval number [1] 290000 0

Summary
Brief summary
Context
Appendicectomy for acute appendicitis is the most common emergency abdominal operation performed for children. We routinely perform the operation laparoscopically because it is known to reduce pain after surgery; however, post-operative pain can still be severe. We hypothesise that the peritoneum may contribute substantially children's discomfort.
Objectives
To test the efficacy of peritoneal local anaesthetic on post-operative pain in laparoscopic appendicectomy for acute appendicitis.
Methods
Children and their caregivers will be invited to participate in a randomized blinded placebo controlled clinical trial on peritoneal local anaesthetic in laparoscopic appendicectomy. After obtaining informed consent for both the laparoscopic procedure and the trial, children will be randomized to receive either local anaesthetic (0.125% bupivacaine) or saline (0.9% sodium chloride) sprayed onto the peritoneum of the right iliac fossa and pelvis. The primary outcome will be pain scores, global pain and also localised pain as measured by a novel pain location tool developed and validated by our unit (the Location and Level of Intensity of Post-operative Pain Score - Lolipops).
Benefits
Reducing children's pain is patently beneficial. An effect of less pain is lower opiate requirements, benefiting children by avoiding nausea, itch, and other unpleasant side effects. Furthermore, shorter hospital stays and even day case surgery may be possible; the health system could benefit substantially from shorter hospital stays and lower costs.
Trial website
Trial related presentations / publications
Hamill JK, Liley A, Hill AG. Intraperitoneal Local Anesthetic for Laparoscopic Appendectomy in Children: A Randomized Controlled Trial. Annals of surgery. 2016 Aug 17.
Public notes
Attachments [1] 626 626 0 0
/AnzctrAttachments/365082-Study Protocol v4a.pdf

Contacts
Principal investigator
Name 43386 0
Dr James Hamill
Address 43386 0
Starship Children's Hospital
Private Bag 92024
Auckland 1142
Country 43386 0
New Zealand
Phone 43386 0
+64 9 3797440
Fax 43386 0
Email 43386 0
[email protected]
Contact person for public queries
Name 43387 0
James Hamill
Address 43387 0
Starship Children's Hospital
Private Bag 92024
Auckland 1142
Country 43387 0
New Zealand
Phone 43387 0
+64 9 3797440
Fax 43387 0
Email 43387 0
[email protected]
Contact person for scientific queries
Name 43388 0
James Hamill
Address 43388 0
Starship Children's Hospital
Private Bag 92024
Auckland 1142
Country 43388 0
New Zealand
Phone 43388 0
+64 9 3797440
Fax 43388 0
Email 43388 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

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