None listed
Conditions
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.
Interventions
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
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.
Sponsors
The University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
- Allergy or contraindication to lignocaine - Unable to consent due to cognitive impairment - Unwilling to consent
Outcome results
None listed