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Trial registered on ANZCTR


Registration number
ACTRN12617000398303
Ethics application status
Approved
Date submitted
11/03/2017
Date registered
17/03/2017
Date last updated
17/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of continuous wound infusion of local anaesthetic agent (Bupivacaine) for pain relief in new born babies undergoing major abdominal surgery
Scientific title
Randomised controlled trial of continuous wound infusion of Bupivacaine for postoperative analgesia in neonates undergoing major abdominal surgery
Secondary ID [1] 291429 0
None
Universal Trial Number (UTN)
U1111-1194-1716
Trial acronym
CLAWI (Continuous Local Anaesthetic Wound Infusion) trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain in neonates following major abdominal surgery 302445 0
Condition category
Condition code
Anaesthesiology 302012 302012 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Irrespective of which group the neonate will be randomised to, all study subjects will have access to systemic opioid analgesia by titratable intravenous infusion as per the current unit policy.
INTRA-OPERATIVE MANAGEMENT OF BOTH GROUPS:
Anaesthesia will be conducted according to current standards of care at the Children's Hospital at Westmead with several provisos. Anaesthesia induction will be either gaseous (oxygen and sevoflurane with or without nitrous oxide) or intravenously at the discretion of the consultant anaesthetist. Muscle relaxation (vecuronium or cis-atracurium), ventilation and intra-operative opioid analgesia will similarly be at the discretion of the anaesthetist. Intra-venous paracetamol will be administered regularly (10mg/Kg/dose qid for 72hours) and may commence intra-operatively. Adjunct analgesic agents such as – IV NSAIDs, ketamine, dexmeditomidine and clonidine will not be used. At the conclusion of surgery and before wound closure, a multi-hole wound catheter (appropriate to the size of the wound) will be inserted under direct vision in babies randomised to treatment group (see below). A bolus dose of local anaesthetic agent (0.3mL/Kg 0.25% Bupivacaine) will be injected through the catheter after wound closure. The catheter will then be capped until return to the Grace Centre of Newborn Care. The decision to extubate the baby at the conclusion of the surgery will be at the discretion of the anaesthetist.
When the incision is closed, the transversus abdominis muscle with/without the peritoneum is closed first. The multi-orifice 19-gauge wound catheter of length 2.5 or 6.5 cm according to the length of the surgical incision is placed superficial to this layer but deep to the internal oblique so that the local anaesthetic/normal saline delivered can come in close contact with the cutaneous nerves which is embedded between the transversus and internal oblique muscle. The internal oblique and external oblique muscles are closed in one layer on top of the wound catheter. A transparent dressing will be applied on the skin. Immediately after skin closure, following a negative aspiration test to confirm that the tip of the catheter is not inserted intravenously, a bolus dose of bupivacaine will be administered through the wound catheter in babies who were randomised to treatment group.
TREATMENT GROUP:
Treatment group will have their wound catheters connected to a continuous infusion of bupivacaine (0.125%) after four hours from the surgery. The infusions will run at 0.16mL/kg/hr for 72 hours.
CONTROL GROUP:
Management of postoperative pain will be as per the current unit protocol.
Intervention code [1] 297465 0
Treatment: Drugs
Comparator / control treatment
Management of postoperative pain will be as per the current unit protocol which includes continuous intravenous infusion of morphine or fentanyl, intermittent boluses of morphine and/or IV paracetamol
Control group
Active

Outcomes
Primary outcome [1] 301442 0
The cumulative amount of intravenous opioid dose per patient per kg of body weight during the first 72 hours following the surgery. This will be a sum of continuous infusion and the intermittent boluses of morphine. The dose of morphine given by continuous infusion will be calculated at the end of IV morphine infusion by multiplying the time (to the closest 15 min) and dose (microgram/kg/hr). If the baby receives fentanyl infusion and/or intermittent boluses, they will be converted to an equivalent dose of morphine.
Timepoint [1] 301442 0
72 hours from the closure of the abdominal wound in the theatre.
Secondary outcome [1] 332667 0
Pain scores: The pain is assessed by the nurse looking after the baby using the Pain Assessment Tool (PAT). Pain scores will be recorded every 2 hours for first 24hours starting from the closure of laparotomy wound and then 4 hourly for the next seven days or until discharge home. If the baby is transferred to another hospital or ward, they will be provided with the information sheet about scoring the pain and recording.
Timepoint [1] 332667 0
Every 2hours for first 24hours starting from the closure of laparotomy wound and then 4 hourly for the next seven days or until discharge home.
Secondary outcome [2] 332668 0
Number of babies requiring rescue opioid boluses.
Timepoint [2] 332668 0
72hours from the closure of laparotomy wound
Secondary outcome [3] 332669 0
The cumulative amount of oral morphine received during the hospital stay.
Timepoint [3] 332669 0
discharge from NICU
Secondary outcome [4] 332670 0
The need for oral morphine at the time of discharge home.
Timepoint [4] 332670 0
Discharge from NICU
Secondary outcome [5] 332671 0
The cumulative amount of enteral/parenteral paracetamol (or other NSAIDS) given for analgesia
Timepoint [5] 332671 0
72hours from the closure of laparotomy wound
Secondary outcome [6] 332672 0
Number of babies with hypotension (defined as the mean arterial pressure less than gestational age of the baby) requiring inotropic support
Timepoint [6] 332672 0
72hours from the closure of laparotomy wound
Secondary outcome [7] 332673 0
Number babies still ventilated at the end of 72 hours postoperatively
Timepoint [7] 332673 0
72hours from the closure of laparotomy wound
Secondary outcome [8] 332674 0
Laparotomy wound infection, defined as erythema of wound edges where surgical team/neonatologists start antibiotics
Timepoint [8] 332674 0
till discharge home from NICU
Secondary outcome [9] 332675 0
Accidental removal of wound catheter, defined as unintentional removal of the catheter before the intentional removal at the end of 72hours from insertion.
Timepoint [9] 332675 0
Till 72hours from the closure of laparotomy wound
Secondary outcome [10] 332676 0
Incidence of side effects of bupivacaine like cardiac arrhythmia, seizures
Timepoint [10] 332676 0
72hours from the closure of wound
Secondary outcome [11] 332843 0
Neurodevelopmental outcome at three months, one and three years of corrected age assessed by Bayley Scales of Infant and Toddler Development III, performed by trained assessors in the Grace Development Clinic (GDC) at The Children's Hospital at Westmead.
Timepoint [11] 332843 0
3months, one year and three years of age

Eligibility
Key inclusion criteria
All babies in the Grace Centre for Newborn Care (GCNC) at the Children's Hospital at Westmead, who are undergoing a laparotomy for congenital or acquired abdominal conditions and who are likely to be admitted in GCNC for at least 72 hours (duration of intervention).
Minimum age
0 Hours
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abdominal surgeries performed laparoscopically
Neonates who were enrolled once in the study but who are undergoing another laparotomy for the same or different surgical condition are not included again
Any absolute contraindication to wound catheter placement
Documented severe liver dysfunction i.e. INR >2.5, liver enzymes >3 times the normal

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)
The random sequence generated will be written on a sheet of paper and kept in non-resealable sealed thick opaque envelopes and stored in the Grace Centre for Newborn Care. The envelopes will be sequentially numbered on the outside. The box containing the envelopes will be kept in the medication (pharmacy) room of GCNC, which is accessible only to the clinical nursing unit manager during the day and the nursing team leader during the night.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence with variable block sizes will be generated using random number generator with “R statistical software”.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
All the continuous variables will be reported as mean (standard deviation) if they are normally distributed or median (interquartile range) if not. Differences between the groups will be examined by student's t-test for continuous variables or appropriate non-parametric alternative and relative risk for categorical outcomes. The pain scores will be analysed by comparing the maximum / minimum pain scores between the groups over the 72hours following the surgery. The statistical analysis will be ‘intention to treat' i.e. all the study participants are included in the analysis as part of their original group to which they were randomised regardless of whether they complete the study or not or whether they took the intended treatment or not. The ‘R software for statistical computing' will be used for all statistical analyses and construction of graphs.
If there are any losses to follow up or where three year outcomes are not possible to be ascertained, we will perform sensitivity analysis. This is done by assigning the worst outcomes to treatment group and best outcomes to the control group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
Date of last participant enrolment
Anticipated
31/03/2019
Actual
Date of last data collection
Anticipated
31/05/2022
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7658 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 15572 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 295625 0
Hospital
Name [1] 295625 0
The Children's Hospital at Westmead
Country [1] 295625 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr Hawkesbury Road & Hainsworth St, Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 294466 0
None
Name [1] 294466 0
Address [1] 294466 0
Country [1] 294466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296946 0
Human Research Ethics Committe, The Sydney Children's Hospital Network
Ethics committee address [1] 296946 0
Ethics committee country [1] 296946 0
Australia
Date submitted for ethics approval [1] 296946 0
29/09/2016
Approval date [1] 296946 0
15/12/2016
Ethics approval number [1] 296946 0
HREC/16/SCHN/371

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72506 0
Dr Rajeshwar Reddy Angiti
Address 72506 0
Department of Neonatology, The Grace Centre for Newborn Care
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
WESTMEAD NSW 2145
Country 72506 0
Australia
Phone 72506 0
+61298450000
Fax 72506 0
Email 72506 0
Rajeshwar.Angiti@health.nsw.gov.au
Contact person for public queries
Name 72507 0
Rajeshwar Reddy Angiti
Address 72507 0
Department of Neonatology, The Grace Centre for Newborn Care
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
WESTMEAD NSW 2145
Country 72507 0
Australia
Phone 72507 0
+61298450000
Fax 72507 0
Email 72507 0
Rajeshwar.Angiti@health.nsw.gov.au
Contact person for scientific queries
Name 72508 0
Rajeshwar Reddy Angiti
Address 72508 0
Department of Neonatology, The Grace Centre for Newborn Care
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
WESTMEAD NSW 2145
Country 72508 0
Australia
Phone 72508 0
+61298450000
Fax 72508 0
Email 72508 0
Rajeshwar.Angiti@health.nsw.gov.au

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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