Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
tDCS sham motor cortex
active prefrontal cortex stimulation
active motor cortex stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria: the participant who has any history of:
- 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
Sites / Locations
- Saeid Metwaly Elsawy
- Saeid Elsawy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Active Comparator
Arm Label
tDCS sham motor cortex
Active motor cortex stimulation
active prefrontal cortex stimulation
Arm Description
25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.
25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.
25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain severity assessment using visual analogue scale (VAS score from 0-10)
the investigator will assess the pain at base line and at the end of sessions
HADS score
hospital anexiety and depression score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03278184
Brief Title
Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery
Official Title
The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The combination of analgesic drugs acting on different mechanisms can potentiate the effects of analgesia. Moreover, the understanding of pain physiology at the molecular level supports the development of new specific drugs. Indeed, new neurophysiological models of pain processing by the brain are becoming exquisitely refined and are supported by electrophysiological and functional brain imaging studies. One of the interesting concepts that stemmed from these studies is the evidence that the experience of pain is reflected in the central nervous system by widespread activations and excitability changes within a network of interconnected cortical areas and subcortical structures. The network processing of noxious information and their limbic and emotional consequences has been termed the "pain matrix." The continuous observation of the activity and excitability changes that parallel the pain experience led to the development of a new therapeutic approach: the use of central nervous system stimulation techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS sham motor cortex
Arm Type
Sham Comparator
Arm Description
25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.
Arm Title
Active motor cortex stimulation
Arm Type
Active Comparator
Arm Description
25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.
Arm Title
active prefrontal cortex stimulation
Arm Type
Active Comparator
Arm Description
25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.
Intervention Type
Device
Intervention Name(s)
tDCS sham motor cortex
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
active prefrontal cortex stimulation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
active motor cortex stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
the total consumption of morphine administered by patients during the first two days postoperative
Description
the investigator will calculate the amount of morphine used during the first two days postoperative.
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
Pain severity assessment using visual analogue scale (VAS score from 0-10)
Description
the investigator will assess the pain at base line and at the end of sessions
Time Frame
30 minutes after every sessions and at the third day
Title
HADS score
Description
hospital anexiety and depression score
Time Frame
before surgery and at the third day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria: the participant who has any history of:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeid M Elsawy, MBBch
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saeid Metwaly Elsawy
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Facility Name
Saeid Elsawy
City
London
ZIP/Postal Code
N15 4DW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery
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