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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03105193




Registration number
NCT03105193
Ethics application status
Date submitted
23/03/2017
Date registered
7/04/2017
Date last updated
3/11/2020

Titles & IDs
Public title
Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
Scientific title
Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
Secondary ID [1] 0 0
IPL/IVL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Colon Resection 0 0
Perioperative Analgesia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IV Saline bolus and infusion
Treatment: Drugs - IP Saline bolus and infusion
Treatment: Drugs - IV lignocaine bolus and infusion
Treatment: Drugs - IP Lignocaine bolus and infusion

Experimental: Intraperitoneal Lignocaine - IP Lignocaine

Experimental: Intravenous lignocaine - IV lignocaine


Treatment: Drugs: IV Saline bolus and infusion
Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump

Treatment: Drugs: 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.

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

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Morphine consumption
Timepoint [1] 0 0
3 days
Secondary outcome [1] 0 0
Pain scores
Timepoint [1] 0 0
0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7
Secondary outcome [2] 0 0
Systemic Inflammatory Response (CRP and WBC)
Timepoint [2] 0 0
very morning post op starting day 1 until day 4 post op
Secondary outcome [3] 0 0
Systemic Local Anesthetic Level
Timepoint [3] 0 0
every morning post op starting day 1 until day 4 post op
Secondary outcome [4] 0 0
Length of stay
Timepoint [4] 0 0
Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Secondary outcome [5] 0 0
Return of bowel function
Timepoint [5] 0 0
Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Secondary outcome [6] 0 0
Readmissions complications
Timepoint [6] 0 0
30 days post op
Secondary outcome [7] 0 0
Surgical recovery scores (SRS)
Timepoint [7] 0 0
Up to 60 days post op

Eligibility
Key inclusion criteria
* consecutive consenting patients undergoing elective laparoscopic colonic resections will be recruited from surgical outpatient clinics at Manukau Super Clinic.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT03105193
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew G Hill
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03105193