NCT03030560

Brief Summary

Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_2 postoperative-pain

Timeline
Completed

Started Apr 2015

Typical duration for phase_2 postoperative-pain

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

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

January 22, 2017

Last Update Submit

November 23, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • numerical rating scale (NRS), pain score.

    Postoperative numerical rating scale (NRS), pain score.

    Postoperative 3 months

Secondary Outcomes (2)

  • opioid consumption.

    Postoperative 24 h

  • Serum cortisol.

    Postoperative 24 h

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

Patients will receive lidocaine infusion.

Drug: Lidocaine

Control group

PLACEBO COMPARATOR

Patients will receive 0.9% Sodium-chloride infusion infusion

Drug: 0.9% Sodium-chloride

Interventions

LidocaineDRUG

patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.

Also known as: Xylocaine
Lidocaine group
0.9% Sodium-chlorideDRUG

patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.

Also known as: Normal saline
Control group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation

You may not qualify if:

  • Previous spinal fusion surgery.
  • Morbid obesity (BMI \> 40)
  • Diagnosis of spinal metastatic cancer
  • Allergy to an amide local anesthetic or morphine sulfate
  • History of renal dysfunction, liver dysfunction or congestive heart failure
  • History of substance abuse disorder.
  • Chronic opioid use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

  • de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.

    PMID: 20682165BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LidocaineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mohamed G Abdelraheem, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of anesthesia and ICU

Study Record Dates

First Submitted

January 22, 2017

First Posted

January 25, 2017

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)