Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000991617p
Ethics application status
Submitted, not yet approved
Date submitted
28/07/2023
Date registered
11/09/2023
Date last updated
11/09/2023
Date data sharing statement initially provided
11/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Lignocaine intraperitoneal implant for pain relief in colectomy
Scientific title
Phase I trial: Safety of a lignocaine eluting intraperitoneal implant for pain relief in elective laparoscopic colectomy
Secondary ID [1] 310223 0
None
Universal Trial Number (UTN)
U1111-1295-9113
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon disease 330909 0
Colon cancer 330910 0
Condition category
Condition code
Surgery 327692 327692 0 0
Other surgery
Anaesthesiology 327693 327693 0 0
Pain management
Cancer 327963 327963 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 327964 327964 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
This is a Phase I study designed to assess the safety of a novel intraperitoneal lignocaine eluting device following colon surgery. The participants will have a local anaesthetic implant placed via a laparoscopic port into the abdominal cavity at the end of the surgical procedure.

The dose administered will be determined by the length of the lignocaine eluting device, which will be based on individual patient's ideal body weight. Our lignocaine eluting device has 16.1 mg lidocaine per cm of co-extrudate, which converts to 1.61g/metre. Our previous randomized controlled trial comparing intraperitoneal and intravenous lignocaine for pain relief following colectomy used a continual infusion dose of 1.5mg/kg/hour. We will use this same dose, but this calculation is complicated by the fact that our lignocaine eluting device will release more lignocaine at the start of the 72 hour period compared to the end of the 72 hour period. We estimate 40% of the drug load is released over 24 hours and 65% of the drug load is released over 48 hours.

At 72 hours the implant will be removed on the ward by the investigator. Post-operative care will be standardised based on an established Enhanced Recovery After Surgery (ERAS) protocol. This involves a standardised multimodal pain protocol whereby patients self-administer opioids based on their pain levels, via a patient-controlled analgesia device.
Intervention code [1] 326612 0
Treatment: Drugs
Intervention code [2] 326820 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335495 0
The primary outcome is frequency of adverse effects and complications related, or possibly related, to the lignocaine eluting intraperitoneal device. Data will be extracted from consenting patient's medical records. These will be graded in terms of severity in accordance with the Clavien Dindo classification for surgical complications.
Timepoint [1] 335495 0
Adverse effects and complications following a 72 hour postoperative period.
Secondary outcome [1] 424802 0
Opioid usage will be assessed, using patient electronic medical records to analyze the frequency and amounts administered to patients in the postoperative period. Different opioids will be converted to morphine equivalent doses in order to have direct comparisons.
Timepoint [1] 424802 0
Mean opioid usage over a 72 hour period following colectomy.
Secondary outcome [2] 425781 0
Serum lignocaine concentrations will be taken and sent to The University of Auckland's pharmacology laboratory for analysis.
Timepoint [2] 425781 0
Serum lignocaine concentrations post-operatively at 30 minutes, 1 hour, 2 hours, 6 hours, day 1, day 2 and day 3.
Secondary outcome [3] 425782 0
Length of stay will be assessed in days, using patient electronic medical records including discharge summaries.
Timepoint [3] 425782 0
Length of stay in hospital (days) following colectomy

Eligibility
Key inclusion criteria
- Adult patients presenting to Manukau Surgery Centre (MSC), Counties Manukau Health (CMH) for elective laparoscopic colectomy
- Presence of malignant or benign disease of the colon
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Allergy or contraindication to lignocaine
- Unable to consent due to cognitive impairment
- Unwilling to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Ten participants will be recruited for our phase I study to demonstrate safety of the device in humans. Provided our phase I study demonstrates appropriate safety of our novel device, we will conduct a randomized controlled trial with our novel device as the intervention and a sham device as the placebo based control, for which detailed statistical analysis will be provided in a subsequent clinical trial form.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25671 0
New Zealand
State/province [1] 25671 0
Auckland

Funding & Sponsors
Funding source category [1] 314385 0
University
Name [1] 314385 0
The University of Auckland
Country [1] 314385 0
New Zealand
Funding source category [2] 314632 0
Commercial sector/Industry
Name [2] 314632 0
DEC NZ
Country [2] 314632 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medical and Health Sciences, The University of Auckland,85 Park Road, Grafton, Auckland 1023, New Zealand
Country
New Zealand
Secondary sponsor category [1] 316339 0
Hospital
Name [1] 316339 0
Middlemore Hospital
Address [1] 316339 0
Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland 2025,New Zealand
Country [1] 316339 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313792 0
Northern A Health and Disability Ethics Committee.
Ethics committee address [1] 313792 0
Ministry of Health, 133 Molesworth Street, PO Box 5013, Wellington 6011, New Zealand
Ethics committee country [1] 313792 0
New Zealand
Date submitted for ethics approval [1] 313792 0
31/07/2023
Approval date [1] 313792 0
Ethics approval number [1] 313792 0

Summary
Brief summary
Current approaches to managing post-operative pain in abdominal surgery rely on opioids. Opioids provide strong analgesia but have negative side effects, and are associated with slower recovery after surgery and delays in patient mobilisation. Local anaesthetic agents are being increasingly utilised worldwide to decrease the post-operative burden of opioids.

We have been studying the benefits of administering local anaesthetic into the abdominal cavity in surgical patients for over ten years. We have developed an implantable local anaesthetic device which is placed into the abdominal cavity intra-operatively and immediately provides continuous delivery of lignocaine. This device has been designed with the specific goal of improving pain control following abdominal surgery, and the device is removed on the ward 72 hours following surgery. The device has been developed with DEC Pharmaceuticals, a Hamilton-based MedTech company. We have demonstrated the safety of this device in a sheep model.

We are planning to conduct a Phase 1 study of our implant with ten participants who are undergoing elective laparoscopic colectomy. The aim of this Phase 1 study is to demonstrate safety of the implant in humans. Following the Phase 1 study, we are planning to conduct a double-blind placebo randomized controlled trial to demonstrate efficacy of the lignocaine eluting intraperitoneal implant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128310 0
Prof Andrew Hill
Address 128310 0
South Auckland Clinical Campus,Level 2, North Wing, Esmé Green Building 30, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland 2025,New Zealand
Country 128310 0
New Zealand
Phone 128310 0
+64 92760044
Fax 128310 0
Email 128310 0
[email protected]
Contact person for public queries
Name 128311 0
Andrew Hill
Address 128311 0
South Auckland Clinical Campus,Level 2, North Wing, Esmé Green Building 30, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland 2025,New Zealand
Country 128311 0
New Zealand
Phone 128311 0
+64 92760044
Fax 128311 0
Email 128311 0
[email protected]
Contact person for scientific queries
Name 128312 0
Andrew Hill
Address 128312 0
South Auckland Clinical Campus,Level 2, North Wing, Esmé Green Building 30, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland 2025,New Zealand
Country 128312 0
New Zealand
Phone 128312 0
+64 92760044
Fax 128312 0
Email 128312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be de-identified and age/gender and primary/secondary outcome data will be available upon request.
When will data be available (start and end dates)?
The dataset will be stored securely on REDCap. The dataset will be available for 5 years following completion of the draft manuscript. After 5 years, the dataset will be destroyed.
Available to whom?
Researchers who provide an appropriate request to the researchers.
Available for what types of analyses?
For purposes related to the broad goal of improving postoperative pain following major abdominal surgery.
How or where can data be obtained?
Data will be available upon request via email correspondence with the primary investigator ([email protected]).


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
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