Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy

April 28, 2020 updated by: Dr Loh Pui San, University of Malaya

Intravenous Lignocaine Infusion as a Multimodal Analgesic Approach in Laparoscopic Donor Nephrectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

Patients who receive intravenous lignocaine infusion as a multimodal analgesic technique will require less morphine postoperatively with lower pain scores on the visual analogue scale (VAS).

Methodology The main clinical study is a randomized double blinded control trial that will start after ethics approval from UMREC and registration at Clinical Trial Registry. All adults undergoing elective laparoscopic donor nephrectomy will be recruited in this double-blinded randomised controlled trial. After obtaining their informed consent, patients will be shown the visual analogue score (VAS) as the post-operative pain assessment and their baseline pain scores obtained. Instructions are also given for patient controlled analgesic (PCA) device using morphine for post-operative pain control.

Randomisation and blinding:

There will be two groups - lignocaine and control. Randomization will be based on a computer generated random number and sealed in opaque envelopes. On the day of surgery, one of the investigators who must not be involved in the care of the case, opens the envelope to follow the allocated group number and prepare either lignocaine or normal saline solutions. Both syringes are labelled with the assigned number only and handed to the attending anaesthesiologist in charge of the surgery. The patient as well as the attending anaesthetic team is blinded to the allocated group. Similarly, post-operative observers who collect the required data will be blinded.

Sample size:

Sample size is calculated based on a pilot study. A power analysis revealed that 15 patients in each group is required to detect a difference of 6 mg between the morphine consumption of the two groups for a power of 80% and and a level of statistical significance at 5%. To provide adequate power for additional analysis, we planned to enrol 20 patients in each group with further allowance for 10% drop out for the per protocol analysis.

Conduct of anaesthesia All patients are administered general anaesthesia with 2mcg/kg of fentanyl, 2-3mg/kg of propofol and 0.6mg/kg of rocuronium for induction, intubated and maintained with desflurane in oxygen-air mixture to MAC of 1.0-1.3. Haemodynamic parameters are measured with standard monitoring and kept within 10% of baseline. All management of ventilation, temperature control and fluids will be done according to institutional protocol for renal transplant.

Study drug protocol 2 groups - Control OR Lignocaine group. Lignocaine group: After induction, securing airway and intravenous lines, patients are turned lateral into the lateral decubitus nephrectomy position. Once the correct position is achieved and haemodynamic status is stable, a slow bolus of 1.5mg/kg of 1% lignocaine is given over 15 min before the start of surgery, followed by an infusion at 1.5mg/kg/hr for the lignocaine group. If the patient's BMI is >30, the ideal body weight (IBW) is used to calculate the bolus and infusion dose at a maximal rate of 100mg/hr for a wide margin of safety.

Control group: An equivalent volume of normal saline is given.

Multimodal analgesia All patients will receive

  • 0.05-0.1 mg/kg of intravenous morphine intra-operatively.
  • One gram of intravenous paracetamol and 40mg of intravenous parecoxib (30min before end of surgery) unless contraindicated.
  • Anti-emetics - dexamethasone 4mg and IV ondansetron 4mg
  • 20-30 mls of plain bupivacaine 0.5% (not exceeding 2mg/kg) will be infiltrated subcutaneously

In the recovery room, the PCA device is set to deliver 1mg bolus of morphine without a baseline infusion, lockout period of 5 min and maximum of 30mg morphine in 4 hours.

  • The time to first PCA use is noted.
  • Pain scores using VAS will be recorded at 30 min, 1 hour, 6 hours, 12 hours and 24 hours post-operatively.
  • Other symptoms such as sedation, nausea, vomiting, light headedness, perioral numbness, and pruritus are reported if it occurs during the first postoperative day.

In the ward, oral paracetamol 1g 6hourly and oral celecoxib 200mg 12hourly will be prescribed for administration in the ward. Total IV morphine consumption at the end of the 24 hours are recorded.

Demographic data, medical history, physical examination, pre- and postoperative laboratory results for renal function (eGFR and creatinine clearance) will be collected prospectively. All post-operative pain scores/ satisfaction scores/ complications will be reviewed and recorded by a blinded observer.

4 blood samples will be taken from every recruited patient - baseline pre-op, before nephrectomy, after nephrectomy and 24 hours post-op.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • University Malaya
        • Contact:
          • University Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective laparoscopic donor nephrectomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lignocaine group
20 patients undergoing elective laparoscopic donor nephrectomy will be given lignocaine infusion as part of the perioperative pain management.
Drug: Lignocaine
Slow bolus of lignocaine is given over 15 min before the start of surgery, followed by infusion of lignocaine
Other Names:
  • Intravenous lignocaine
Active Comparator: Control group
20 patients undergoing elective laparoscopic donor nephrectomy will be receiving an equivalent volume of normal saline.
Drug: Normal saline
An equivalent volume of normal saline is given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morphine requirement
Time Frame: 24 hours postoperatively
Morphine usage post-operatively
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of systemic lignocaine
Time Frame: before lignocaine infusion, after lignocaine infusion just before nephrectomy, half hour after nephrectomy, within 24 post operatively
Serial venous blood are taken at 4 different intervals
before lignocaine infusion, after lignocaine infusion just before nephrectomy, half hour after nephrectomy, within 24 post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Pui San Loh, MBBS, MMed, University Malaya, Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2019

Primary Completion (Anticipated)

July 15, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1237-9350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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