NCT04052867

Brief Summary

Background: Administration of morphine as boluses or via a patient controlled analgesic device (PCA) has been the standard practice for donors after nephrectomy. However, administration of morphine is far from being ideal analgesic as it does not provide optimal dynamic pain relief after major surgery, consistently demonstrate little effect on surgical stress response and organ dysfunction with high incidences of postoperative nausea/vomiting, respiratory depression and sedation. Several studies demonstrated perioperative intravenous lignocaine infusion can improve post-operative pain scores and morphine consumption in abdominal surgery. The aim of this study is to identify the effectiveness of intra-operative lignocaine infusion in lowering postoperative pain and reduce postoperative morphine consumption in patients who undergo laparoscopic donor nephrectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

August 8, 2019

Last Update Submit

April 28, 2020

Conditions

Postoperative PainRenal TransplantationMorphine Adverse Reaction

Keywords

Intravenous lignocaineMultimodal anagesic approachPostoperative Painliving related renal transplantationMorphine

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine requirement

    Morphine usage post-operatively

    24 hours postoperatively

Secondary Outcomes (1)

  • Level of systemic lignocaine

    before lignocaine infusion, after lignocaine infusion just before nephrectomy, half hour after nephrectomy, within 24 post operatively

Study Arms (2)

Lignocaine group

EXPERIMENTAL

20 patients undergoing elective laparoscopic donor nephrectomy will be given lignocaine infusion as part of the perioperative pain management.

Drug: Lignocaine

Control group

ACTIVE COMPARATOR

20 patients undergoing elective laparoscopic donor nephrectomy will be receiving an equivalent volume of normal saline.

Drug: Normal saline

Interventions

LignocaineDRUG

Slow bolus of lignocaine is given over 15 min before the start of surgery, followed by infusion of lignocaine

Also known as: Intravenous lignocaine
Lignocaine group
Normal salineDRUG

An equivalent volume of normal saline is given

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic donor nephrectomy

You may not qualify if:

  • refuse consent
  • allergic to local anaesthetics or opioids,
  • on long term analgesics for chronic pain,
  • have impaired liver function
  • has history of arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (11)

  • Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.

    PMID: 23150820BACKGROUND

  • Waller JR, Hiley AL, Mullin EJ, Veitch PS, Nicholson ML. Living kidney donation: a comparison of laparoscopic and conventional open operations. Postgrad Med J. 2002 Mar;78(917):153-7. doi: 10.1136/pmj.78.917.153.

    PMID: 11884697BACKGROUND

  • Gerbershagen HJ, Dagtekin O, Rothe T, Heidenreich A, Gerbershagen K, Sabatowski R, Petzke F, Ozgur E. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009 Sep;13(8):853-60. doi: 10.1016/j.ejpain.2008.10.001. Epub 2008 Nov 14.

    PMID: 19010073BACKGROUND

  • Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.

    PMID: 12402719BACKGROUND

  • Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.

    PMID: 27199310BACKGROUND

  • Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.

    PMID: 23044681BACKGROUND

  • Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.

    PMID: 26184397BACKGROUND

  • Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

    PMID: 21061107BACKGROUND

  • McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.

    PMID: 20518581BACKGROUND

  • Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.

    PMID: 17197840BACKGROUND

  • Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.

    PMID: 28114177BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Pui San Loh, MBBS, MMed

    University Malaya, Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pui San Loh, MBBS, MMed

CONTACT

012-2268285lohps@ummc.edu.my

Sook Hui Chaw, MD

CONTACT

sook_hui@ummc.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthesiologist

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 12, 2019

Study Start

September 17, 2019

Primary Completion

July 15, 2021

Study Completion

July 31, 2021

Last Updated

April 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)