NCT03278184

Brief Summary

The experience of pain derives from changes in brain excitability. Therefore, modulating the excitability of cortical areas involved in pain processing may become an attractive option in the context of multimodal analgesia during the postoperative period.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

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

September 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

September 5, 2017

Last Update Submit

December 11, 2021

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • the total consumption of morphine administered by patients during the first two days postoperative

    the investigator will calculate the amount of morphine used during the first two days postoperative.

    48 hours postoperative

Secondary Outcomes (2)

  • Pain severity assessment using visual analogue scale (VAS score from 0-10)

    30 minutes after every sessions and at the third day

  • HADS score

    before surgery and at the third day

Study Arms (3)

tDCS sham motor cortex

SHAM COMPARATOR

25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.

Device: tDCS sham motor cortex

Active motor cortex stimulation

ACTIVE COMPARATOR

25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.

Device: active motor cortex stimulation

active prefrontal cortex stimulation

ACTIVE COMPARATOR

25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.

Device: active prefrontal cortex stimulation

Interventions

tDCS sham motor cortexDEVICE

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.

tDCS sham motor cortex
active prefrontal cortex stimulationDEVICE

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min

active prefrontal cortex stimulation
active motor cortex stimulationDEVICE

the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min

Active motor cortex stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent to participate in the study.
  • postoperative spine surgery patients(discectomy and/or laminectomy).
  • American society of anesthesiology scores I to II patients.

You may not qualify if:

  • an adverse reaction to brain stimulation.
  • a seizure
  • an unexplained loss of consciousness
  • a stroke
  • serious head injury
  • surgery to their head
  • any brain related, neurological illnesses
  • any illness that may have caused brain injury
  • frequent or severe headaches
  • metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding
  • any implanted medical devices such as cardiac pacemaker's or medical pumps
  • taking any analgesic medications in the past 24 hours
  • pregnancy
  • anyone in your family has epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saeid Metwaly Elsawy

Asyut, 71111, Egypt

Location

Saeid Elsawy

London, N15 4DW, United Kingdom

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Saeid M Elsawy, MBBch

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 11, 2017

Study Start

October 1, 2017

Primary Completion

April 1, 2019

Study Completion

November 1, 2019

Last Updated

December 14, 2021

Record last verified: 2021-12

Locations

EG(1)GB(1)