Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain

Post-Operative Pain Clinical Trial

Official title:

Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861587
• Other study ID #: HR18682
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 2014

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.

Description:

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years-75 years of age

• surgery at Medical University of South Carolina

• at least 2 days of post-operative stay

Exclusion Criteria:

• history of seizures or epilepsy

• family history of seizures

• taking any medications shown to lower seizure threshold

• metal implants above the waist

• pregnant

• brain tumors or lesions

• pacemaker

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain

Intervention

Device:
• tDCS
20 minutes of either real or sham stimulation

Locations

Country	Name	City	State
United States	Brain Stimulation Laboratory, Institute of Psychiatry	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Controlled Analgesia (PCA) Hydromorphone Usage	The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.	Participants were followed for the duration of hospital stay, an average of 48 hours.
Primary	Average Pain at Least	To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.	Baseline and Discharge
Primary	Average Pain at Worst	To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.	Baseline Only
Primary	Average Pain	To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.	Baseline Only