Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections

NCT03105193 | Completed Phase 4 DMC

• 1 other identifier: IPL/IVL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic Colon Resection; Perioperative Analgesia

Keywords

Colon surgery; Lignocaine; Lidocaine; Analgesia; Local anaesthetic

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Total morphine consumption at day 3

  3 days

Secondary Outcomes (7)

• Pain scores

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

• Systemic Inflammatory Response (CRP and WBC)

  very morning post op starting day 1 until day 4 post op

• Systemic Local Anesthetic Level

  every morning post op starting day 1 until day 4 post op

• Length of stay

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

• Return of bowel function

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

Study Arms (2)

Intraperitoneal Lignocaine

EXPERIMENTAL

IP Lignocaine

Drug: IV Saline bolus and infusion; Drug: IP Lignocaine bolus and infusion

Intravenous lignocaine

EXPERIMENTAL

IV lignocaine

Drug: IP Saline bolus and infusion; Drug: IV lignocaine bolus and infusion

Interventions

IV Saline bolus and infusion DRUG

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

Intraperitoneal Lignocaine

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.

Also known as: Lidocaine

Intravenous lignocaine

IV lignocaine bolus and infusion DRUG

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

Also known as: Lidocaine

Intravenous lignocaine

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.

Intraperitoneal Lignocaine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

Manukau Surgical Centre, Middlemore Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Andrew G Hill

  The University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 7, 2017
• Study Start: August 17, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)