NCT03005171

Brief Summary

The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in patients undergoing open upper abdominal surgery; when compared with thoracic epidural analgesia. Half of participants will receive intravenous lidocaine infusion, while the other half will receive thoracic epidural bupivacaine infusion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

December 25, 2016

Last Update Submit

December 6, 2017

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Verbal Numeric Rating Score

    Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants

    2-24 hours

Secondary Outcomes (3)

  • B- endorphin level

    Baseline-24 hours

  • FVC

    Baseline-24 hours

  • FEV1

    Baseline-24 hours

Study Arms (2)

Epidural

ACTIVE COMPARATOR

Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused. The infusion continues for 24h

Drug: Bupivacaine

Lidocaine

ACTIVE COMPARATOR

Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min. The infusion continues for 24h

Drug: Lidocaine

Interventions

BupivacaineDRUG

Thoracic epidural bupivacaine infusion

Also known as: Marcaine
Epidural
LidocaineDRUG

Intravenous lidocaine infusion

Also known as: Xylocaine, Lidocaine Hydrochloride
Lidocaine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing open upper abdominal surgery

You may not qualify if:

  • Bleeding diathesis
  • History of allergy to local anesthetics
  • Pregnancy/ lactation
  • Cardiovascular disease
  • Respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Interventions

BupivacaineLidocaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Officials

  • Assiut University

    Assiut University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 25, 2016

First Posted

December 29, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

December 7, 2017

Record last verified: 2017-12