Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
60

Summary

Conditions
  • Opioid Use Disorder
  • Pain Postoperative
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Among participants who receive a device, both the participant and care providers/investigators will be blinded to whether the device is active or placebo. There is no blinding among participants who do not receive a device.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anes...

This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.

Tracking Information

NCT #
NCT04365465
Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Grace Lim, MD, MS University of Pittsburgh
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