NCT02601651

Brief Summary

The primary objectives of this study is to access the effect of perioperative lidocaine infusion on total morphine requirement during the first 24 h postoperatively in patients who underwent laparoscopic totally extraperitoneal inguinal hernioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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

November 9, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

November 9, 2015

Last Update Submit

September 24, 2018

Conditions

Pain, Postoperative

Keywords

Totally Extraperitoneal Inguinal HernioplastyLidocaine infusionPostoperative opioid consumption

Outcome Measures

Primary Outcomes (1)

  • Total morphine requirement during the first 24 h postoperatively

    24h

Secondary Outcomes (9)

  • Pain at rest and with coughing or movement using the NRS scale

    24h

  • Time to first perception of pain

    24h

  • Incidence of postoperative nausea and vomiting (PONV) will be evaluated on a three-point ordinal scale.

    24h

  • Sedation score using five point scale

    24h

  • Time to first voiding.

    24h

  • +4 more secondary outcomes

Study Arms (2)

Lidocaine

EXPERIMENTAL

Lignocaine group (Group A) will receive an intravenous (IV) bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the tracheal extubation.

Drug: Lidocaine

Normal saline

PLACEBO COMPARATOR

Normal saline group (Group B) will receive an intravenous normal saline bolus at induction followed by continuous infusion of normal saline until the tracheal extubation

Drug: Normal saline

Interventions

LidocaineDRUG

Lignocaine group will receive an intravenous (IV) bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the tracheal extubation.

Also known as: Lignocaine, Loxicard
Lidocaine
Normal salineDRUG

Normal saline group will receive an intravenous normal saline bolus at induction followed by continuous infusion of normal saline until the tracheal extubation

Normal saline

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients with American Society of Anaesthesiologists physical status (ASA PS) I and II of age 18 to 65 years
  • Patients undergoing laparoscopic totally extraperitoneal repair for unilateral/bilateral inguinal hernia.

You may not qualify if:

  • Refusal to give consent.
  • ASA physical status III or more.
  • Inability to comprehend pain assessment score or severe mental impairment
  • Patient who weighed \< 40 kg or \>100 kg
  • Severe underlying cardiac rhythm disorder
  • Renal or hepatic disease
  • Allergic to local anaesthetics
  • Epilepsy
  • Patients on regular analgesics or anti-arrhythmic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BP Koirala institute of health sciences

Dharān, Sunsari, 56700, Nepal

Location

Related Publications (1)

  • Ghimire A, Subedi A, Bhattarai B, Sah BP. The effect of intraoperative lidocaine infusion on opioid consumption and pain after totally extraperitoneal laparoscopic inguinal hernioplasty: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 3;20(1):137. doi: 10.1186/s12871-020-01054-2.

    PMID: 32493276DERIVED

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

  • Asish Subedi, MD

    B.P. Koirala Institute of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 10, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

NE(1)