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The Effects of Transcranial Electrostimulation (TES) on Postoperative Pain and Functional Patient Outcomes After Surgery for Obstructive Sleep Apnea Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Control of this pain may be difficult, because OSA patients are very sensitive to traditional opioid pain medications, and their side effects. Poorly controlled pain slows down patients' recovery after surgery, including a return to normal daily activities and work, and may also delay wound healing. This study will investigate whether pain relief and recovery after surgery may be improved with the application of a weak electrical current to the skin of the patient's head (transcranial electrostimulation, TES). The TES works by blocking pain in the central nervous system through multiple mechanisms, which result in non-pharmacological pain relief, without drug-associated side effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
Locations
United States
California
Stanford Univeristy Medical Center
RECRUITING
Stanford
Time Frame
Start Date: 2017-07-18
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 45
Treatments
Experimental: TES 60 Hz DC:AC
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
Active_comparator: TES 100 Hz DC:AC
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
Sham_comparator: TES with DC current
Transcranial electrostimulation (TES) with direct current (DC) only
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov