Lignocaine intraperitoneal implant for pain relief in colectomy

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-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.
Primary outcome(s): 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. [ Adverse effects and complications following a 72 hour postoperative period.]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety