Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
NCT ID: NCT03105193
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2018-08-17
2019-12-30
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intraperitoneal Lignocaine
IP Lignocaine
IV Saline bolus and infusion
Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump
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.
Intravenous lignocaine
IV lignocaine
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.
IV lignocaine bolus and infusion
Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump
Interventions
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IV Saline bolus and infusion
Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump
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.
IV lignocaine bolus and infusion
Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
16 Years
ALL
Yes
Sponsors
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University of Auckland, New Zealand
OTHER
Responsible Party
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Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS
Prof.
Principal Investigators
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Andrew G Hill
Role: PRINCIPAL_INVESTIGATOR
The University of Auckland
Locations
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Manukau Surgical Centre, Middlemore Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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IPL/IVL
Identifier Type: -
Identifier Source: org_study_id