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Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections

Primary Purpose

Laparoscopic Colon Resection, Perioperative Analgesia

Status
Completed
Phase
Phase 4
Locations
New Zealand
Study Type
Interventional
Intervention
IV Saline bolus and infusion
IP Saline bolus and infusion
IV lignocaine bolus and infusion
IP Lignocaine bolus and infusion
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Colon Resection focused on measuring Colon surgery, Lignocaine, Lidocaine, Analgesia, Local anaesthetic

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Manukau Surgical Centre, Middlemore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intraperitoneal Lignocaine

Intravenous lignocaine

Arm Description

IP Lignocaine

IV lignocaine

Outcomes

Primary Outcome Measures

Morphine consumption
Total morphine consumption at day 3

Secondary Outcome Measures

Pain scores
Pain scores using the visual analogue score (VAS)
Systemic Inflammatory Response (CRP and WBC)
Blood test
Systemic Local Anesthetic Level
Blood test
Length of stay
The day that the patient is discharged will be recorded
Return of bowel function
Time to flatus, first bowel motion
Readmissions complications
Readmissions complications will be recorded up to day 30 post op using the Clavien-Dindo Classification
Surgical recovery scores (SRS)
SRS questionnaires will be administered at day 1 till discharge then POD 14, 30 and 60

Full Information

First Posted
March 23, 2017
Last Updated
November 2, 2020
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT03105193
Brief Title
Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
Official Title
Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Colon Resection, Perioperative Analgesia
Keywords
Colon surgery, Lignocaine, Lidocaine, Analgesia, Local anaesthetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraperitoneal Lignocaine
Arm Type
Experimental
Arm Description
IP Lignocaine
Arm Title
Intravenous lignocaine
Arm Type
Experimental
Arm Description
IV lignocaine
Intervention Type
Drug
Intervention Name(s)
IV Saline bolus and infusion
Intervention Description
Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump
Intervention Type
Drug
Intervention Name(s)
IP Saline bolus and infusion
Other Intervention Name(s)
Lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IV lignocaine bolus and infusion
Other Intervention Name(s)
Lidocaine
Intervention Description
Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump
Intervention Type
Drug
Intervention Name(s)
IP Lignocaine bolus and infusion
Intervention Description
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 Outcome Measure Information:
Title
Morphine consumption
Description
Total morphine consumption at day 3
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Pain scores
Description
Pain scores using the visual analogue score (VAS)
Time Frame
0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7
Title
Systemic Inflammatory Response (CRP and WBC)
Description
Blood test
Time Frame
very morning post op starting day 1 until day 4 post op
Title
Systemic Local Anesthetic Level
Description
Blood test
Time Frame
every morning post op starting day 1 until day 4 post op
Title
Length of stay
Description
The day that the patient is discharged will be recorded
Time Frame
Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Title
Return of bowel function
Description
Time to flatus, first bowel motion
Time Frame
Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Title
Readmissions complications
Description
Readmissions complications will be recorded up to day 30 post op using the Clavien-Dindo Classification
Time Frame
30 days post op
Title
Surgical recovery scores (SRS)
Description
SRS questionnaires will be administered at day 1 till discharge then POD 14, 30 and 60
Time Frame
Up to 60 days post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew G Hill
Organizational Affiliation
The University of Auckland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manukau Surgical Centre, Middlemore Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

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Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections

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