Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections

The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan to run a 2 group randomized, double blind, clinical trial which will look into morphine consumption as the primary outcome.

Group 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal saline infusion

Group 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal saline infusion. IP bolus of lignocaine + 3 day post operative IP lignocaine infusion

Study Overview

• Status: Completed
• Conditions: Laparoscopic Colon Resection; Perioperative Analgesia
• Intervention / Treatment: Drug: IV Saline bolus and infusion; Drug: IP Lignocaine bolus and infusion; Drug: IP Saline bolus and infusion; Drug: IV lignocaine bolus and infusion

Detailed Description

Over the last 20 years, laparoscopic colonic surgery has become an accepted first-line treatment for colon cancer. A population-based study showed that laparoscopic colonic resections can be performed with lower hospital costs up to 90 days after discharge when compared to open surgery. Laparoscopic colonic resections have also been associated with fewer postoperative complications and lower mortality.

New Zealand has one of the highest rates of bowel cancer in the world, and it is the second highest cause of cancer deaths in New Zealand. With the implementation of a bowel screening programme in New Zealand, the projected numbers of stage 1 bowel cancers are expected to increase. More avenues to improve perioperative care need to be explored to improve patient outcomes.

Controlling postoperative pain effectively has been shown to reduce the length of hospital stay and improve patient/clinical outcomes. Opioids work as μ-receptor agonists in the spinal cord and brain, and although opioids are excellent at reducing pain, they are associated with nausea, vomiting, dizziness, decreased blood pressure, and urinary retention. Epidurals have been incorporated into Enhanced Recovery After Surgery protocols for controlling post-operative pain. However, epidurals are an invasive procedure with significant side effects such as hypotension, urinary retention, respiratory depression, motor blockade and rarely epidural abscess and meningitis. It has also been shown that up to 30 percent of epidural catheters dislodge, block or leak. These complications have led to a movement towards other regional analgesia techniques which allow local anaesthetic (LA) to target the abdominal wound specifically.

Intraperitoneal local anaesthetic (IPLA) has shown promise in reducing pain after colonic surgery with a meta-analysis9, and a recent IPLA colorectal study conducted at Counties Manukau health showing that it reduces pain and opioid use over and above the effect of an epidural10, which is primarily aimed at the abdominal wound. After an IPLA bolus serum local anaesthetic levels are detectable within 2 minutes. Some studies show reduced early postoperative pain and opioid consumption with intravenous lignocaine infusion alone. The question remains however if there is a benefit from using intraperitoneal local anaesthetic compared to administering it intravenously as the IPLA should block both the intraabdominal wound, via a local action, and the skin wound via a systemic action.. This has been investigated in four studies, however none of these studies compared intravenous local anaesthetic (IVLA) and IPLA for colon resection.

The aim is that, by optimising analgesia regimes using local anaesthetic, we can improve patient experience of pain and recovery thereby achieving an earlier discharge and early recovery from surgery. This has significant economic benefits for all involved.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Manukau Surgical Centre, Middlemore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• consecutive consenting patients undergoing elective laparoscopic colonic resections will be recruited from surgical outpatient clinics at Manukau Super Clinic.

Exclusion Criteria:

• under 16 years of age
• acute colonic resection
• those with ASA >= 4
• previous adverse reaction/allergy to local anaesthetic,
• surgery for rectal lesions which was defined as lesion within 15 cm of the anal verge
• preoperative systemic steroid dependence
• hepatic dysfunction, opioid use greater than 6 months
• a diagnosis of Chronic Pain Syndrome
• inability to consent or complete data scores in the study questionnaires due to cognitive impairment and/or language barrier.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraperitoneal Lignocaine; IP Lignocaine	Drug: IV Saline bolus and infusion; Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump; Drug: IP Lignocaine bolus and infusion; Intraperitoneal bolus of lignocaine down first port site. 3 day post operative intraperitoneal infusion of lignocaine via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.
Experimental: Intravenous lignocaine; IV lignocaine	Drug: IP Saline bolus and infusion; Intraperitoneal bolus of normal saline down first port site. 3 day post operative intraperitoneal infusion of normal saline via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.; Other Names: Lidocaine; Drug: IV lignocaine bolus and infusion; Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump; Other Names: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Total morphine consumption at day 3	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores using the visual analogue score (VAS)	0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7
Systemic Inflammatory Response (CRP and WBC)	Blood test	very morning post op starting day 1 until day 4 post op
Systemic Local Anesthetic Level	Blood test	every morning post op starting day 1 until day 4 post op
Length of stay	The day that the patient is discharged will be recorded	Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Return of bowel function	Time to flatus, first bowel motion	Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Readmissions complications	Readmissions complications will be recorded up to day 30 post op using the Clavien-Dindo Classification	30 days post op
Surgical recovery scores (SRS)	SRS questionnaires will be administered at day 1 till discharge then POD 14, 30 and 60	Up to 60 days post op

Collaborators and Investigators

• Sponsor: University of Auckland, New Zealand
• Investigators: Principal Investigator: Andrew G Hill, The University of Auckland

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: April 2, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; Lidocaine; Lignocaine; Local anaesthetic; Colon surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IPL/IVL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No