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Completed

NCT Number: NCT03105193

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Manukau Surgical Centre, Middlemore Hospital

Auckland, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV Saline bolus and infusion

Drug

Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump

IP Saline bolus and infusion

Drug

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

IV lignocaine bolus and infusion

Drug

Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump

Other names: Lidocaine

IP Lignocaine bolus and infusion

Drug

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.

Primary outcomes

  1. Morphine consumption

    Time frame: 3 days

    Total morphine consumption at day 3

Secondary outcomes

  1. Pain scores

    Time frame: 0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7

    Pain scores using the visual analogue score (VAS)

  2. Systemic Inflammatory Response (CRP and WBC)

    Time frame: very morning post op starting day 1 until day 4 post op

    Blood test

  3. Systemic Local Anesthetic Level

    Time frame: every morning post op starting day 1 until day 4 post op

    Blood test

  4. Length of stay

    Time frame: Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks

    The day that the patient is discharged will be recorded

  5. Return of bowel function

    Time frame: Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks

    Time to flatus, first bowel motion

  6. Readmissions complications

    Time frame: 30 days post op

    Readmissions complications will be recorded up to day 30 post op using the Clavien-Dindo Classification

  7. Surgical recovery scores (SRS)

    Time frame: Up to 60 days post op

    SRS questionnaires will be administered at day 1 till discharge then POD 14, 30 and 60

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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